Ischemic Heart DiseaseNCT03409731

Absorb GT1 Japan PMS

A study testing ABSORB GT1 BVS in people with Ischemic Heart Disease and Angina Pectoris, run by Abbott Medical Devices at 15 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for evaluating clinical use results. Read more about this study

Who is it for?: Any age
Conditions the study is for: Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease
What is being tested?: ABSORB GT1 BVS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 135 participants
Where: 15 sitesJapan
Study dates: 13 Dec 2016to 6 Feb 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

General Percutaneous coronary intervention (PCI) population.

Who cannot join

No specific exclusion criteria.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Japan15 sites

Mitsui Memorial Museum
Chiyoda City, Tokyo, 101-8643
Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533
Kobe University
Kobe, Hyōgo, 650-0017
Saiseikai Kumamoto Hospital
Kumamoto, 861-4193
Kurashiki Central Hospital
Kurashiki, Okayama-ken, 710-8602
Shin Koga Hospital
Kurume, Fukuoka, 830-8577
Shin Tokyo Hospital
Matsudo, Chiba, 270-2232
Toho University Ohashi Medical Center
Meguro City, Tokyo, 153-8515
Miyazaki Medical Association Hospital
Miyazaki, 880-0834
Iwate Medical University
Morioka, Iwate, 020-8505
Nagoya Daini Red Cross Hospital
Nagoya, Aichi-ken, 466-8650
Sakurabashi Watanabe Hospital
Osaka, 530-0001
Hanaoka Seishu Memorial Cardiovascular Clinic
Sapporo, Hokkaido, 062-0003
Saitama Sekishinkai Hospital
Sayama, Saitama, 350-1323
Teikyo University
tabashi City, Tokyo, 173-8606

Other trials in Japan

About this study

Official title: Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System Post-marketing Surveillance (PMS)

Conditions: Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion, Myocardial Ischemia
Being tested: ABSORB GT1 BVS
Keywords: Drug eluting Bio-resolvable Scaffold (BRS), Bio-resolvable Scaffold (BRS), Real world
Medical subject headings: Myocardial Ischemia, Angina Pectoris, Coronary Artery Disease, Coronary Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABSORB GT1 BVSDevice
Patients receiving Absorb GT1 BVS

Study groups in NCT03409731
Study group	Role	What they receive
Absorb GT1 BVS	Other	Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. Receives: Device: ABSORB GT1 BVS

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Acute Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%).
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation.
Measured: Day 0
Number of Participants With Sub Acute Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%).
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation.
Measured: >1 to 30 days
Number of Participants With Late Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation.
Measured: 31 to 90 days
Number of Participants With Late Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation.
Measured: 31 to 365 days
Number of Participants With Very Late Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation.
Measured: 366 to 730 days
Number of Participants With Overall Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Measured: 0 to 90 days
Number of Participants With Cumulative Scaffold Thrombosis
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%).
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Measured: 0 to 90 days
Number of Participants With Cumulative Scaffold Thrombosis
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%).
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Measured: 0 to 730 days
Number of Participants With Exclusion of Very Small Vessels
For Phase 1 patients, Angiograms and IVUS/OCT images taken during procedure will be sent immediately to the core lab. Additional training or revision of registration criteria may occur as required in order to exclude almost all lesions with RVD < 2.5 mm from registration by the last half of Phase 1.
Measured: During index procedure, "54.8 ± 27.6 min"
Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging
IVUS/OCT images taken during procedure will be sent immediately to the core lab, which will analyze the images and give feedback to the site as required. Images of ST, if occurred, will also be sent to the core lab.
Measured: During index procedure, "54.8 ± 27.6 min"
Number of Participants With Composite of Device Deficiencies
Device deficiencies: Number of participants with at least one of the following Device deficiencies
1. Lesion/implant failure
2. Delivery difficulty (finally delivered)
3. Re-crossing failure
4. Re-crossing difficulty
5. Post-dilatation balloon
6. Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS)
7. Instruction for Use (IFU) not included
8. Major Strut Malapposition
9. Strut Fracture within 6 months
Measured: During index procedure, "54.8 ± 27.6 min"
Number of Participants With Late Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation.
Measured: 731 - 1095 days
Number of Participants With Cumulative Scaffold Thrombosis
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Measured: 0 - 1095 days
Number of Participants With Very Late Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Measured: 1096 - 1460 days
Number of Participants With Cumulative Scaffold Thrombosis
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Measured: 0 - 1460 days
Number of Participants With Cumulative Scaffold Thrombosis
Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation.
Measured: 0 - 1825 days

Secondary outcomes (85)

Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Measured: 0 to 30 days
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Measured: 0 to 90 days
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Measured: 0 to 1 year
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Measured: 0 to 2 years
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Measured: 0 to 30 days
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Measured: 0 to 90 days
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Measured: 0 to 1 year
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Measured: 0 to 2 years
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Measured: 0 to 30 days
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Measured: 0 to 90 days
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Measured: 0 to 1 year
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Measured: 0 to 2 years
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 0 to 30 days
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 0 to 90 days
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 0 to 1 year
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 0 to 2 years
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Measured: 0 to 30 days
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Measured: 0 to 90 days
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Measured: 0 to 1 year
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Measured: 0 to 2 years
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Measured: 0 to 30 days
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Measured: 0 to 90 days
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Measured: 0 to 1 year
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Measured: 0 to 2 years
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 0 to 30 days
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 0 to 90 days
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)
Measured: 0 to 1 Year
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)
Measured: 0 to 2 years
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Measured: 0 to 30 days
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Measured: 0 to 90 days
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Measured: 0 to 1 year
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Measured: 0 to 2 years
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 0 to 30 days
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 0 to 90 days
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 0 to 1 year
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 0 to 2 years
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Measured: 0 to 30 days
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Measured: 0 to 90 days
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Measured: 0 to 1 year
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Measured: 0 to 2 years
Angiographic Endpoints (Core Lab Analysis): Lesion Morphology
Measured: Pre-procedure
Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion.
TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed.
TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory.
TIMI 3 is normal flow which fills the distal coronary bed completely
Measured: Pre-procedure
Angiographic Endpoints (Core Lab Analysis): Lesion Length
Lesion Length (can be measured after successful post-dilatation)
Measured: Pre-procedure
Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD)
Proximal RVD (can be measured after successful post-dilatation)
Measured: Pre-procedure
Angiographic Endpoints (Core Lab Analysis): Distal RVD
Distal RVD (can be measured after successful post-dilatation)
Measured: Pre-procedure
Angiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD)
Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen
Measured: Pre-procedure
Angiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Measured: Pre-procedure
Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion.
TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed.
TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory.
TIMI 3 is normal flow which fills the distal coronary bed completely
Measured: Post-procedure (average procedure time of "54.8 ± 27.6 min")
Angiographic Endpoints (Core Lab Analysis): MLD (In-segment)
Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.
In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Measured: Post-procedure (average procedure time of "54.8 ± 27.6 min")
Angiographic Endpoints (Core Lab Analysis): %DS (In-Segment )
Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Measured: Post-procedure (average procedure time of "54.8 ± 27.6 min")
Angiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment )
The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
Measured: Post-procedure (average procedure time of "54.8 ± 27.6 min")
IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)
Measured: Pre-procedure (or after pre-dilatation)
IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)
Measured: Post-procedure (average procedure time of "54.8 ± 27.6 min")
IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area
Measured: Post-procedure (average procedure time of "54.8 ± 27.6 min")
IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut Malapposition
Percentage of lesions with strut malapposition will be calculated as mean ± standard deviation post-procedure
Measured: Post-procedure (average procedure time of "54.8 ± 27.6 min")
IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut Fracture
Strut fracture will be measured as either number or percentage post-procedure
Measured: Post-procedure (average procedure time of "54.8 ± 27.6 min")
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Measured: 3 years
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Measured: 3 years
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Measured: 3 years
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 3 years
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Measured: 3 years
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Measured: 3 years
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 3 years
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Measured: 3 years
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 3 years
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Measured: 3 years
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Measured: 4 years
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Measured: 4 years
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Measured: 4 years
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 4 years
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Measured: 4 years
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Measured: 4 years
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 4 years
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Measured: 4 years
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 4 years
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Measured: 4 years
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Measured: 5 years
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Measured: 5 years
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Measured: 5 years
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 5 years
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Measured: 5 years
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 5 years
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR).
Measured: 5 years
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 5 years
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 20166 Feb 2023

First posted24 Jan 2018
Study start13 Dec 2016
Primary completion6 Feb 2023
Study completion6 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03409731
Sponsor's protocol ID: 16-310
Status last verified: May 2024
First submitted: 18 May 2017
Last updated: 6 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes

Publications

Nakamura M, Suzuki N, Fujii K, Furuya J, Kawasaki T, Kimura T, Sakamoto T, Tanabe K, Kusano H, Stockelman KA, Kozuma K. The Absorb GT1 Bioresorbable Vascular Scaffold System - 5-Year Post-Market Surveillance Study in Japan. Circ J. 2024 May 24;88(6):863-872. doi: 10.1253/circj.CJ-23-0877. Epub 2024 Mar 13.
PubMed 38479861

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System Post-marketing Surveillance (PMS)
ClinicalTrials.gov ID: NCT03409731
Acronym / sponsor ID: 16-310
Conditions: Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion, Myocardial Ischemia
Keywords: Drug eluting Bio-resolvable Scaffold (BRS), Bio-resolvable Scaffold (BRS), Real world
Study type: Interventional
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: 13 Dec 2016 (actual)
Primary completion: 6 Feb 2023 (actual)
Study completion: 6 Feb 2023 (actual)
First posted: 24 Jan 2018 (actual)
Results: Posted 3 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Absorb GT1 BVS	Other	Device: ABSORB GT1 BVSPatients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

General Percutaneous coronary intervention (PCI) population.

Key exclusion criteria (1 listed)

No specific exclusion criteria.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ABSORB GT1 BVSPatients receiving Absorb GT1 BVS	Device	Absorb GT1 BVS

Primary outcome

Number of Participants With Acute Scaffold Thrombosis (ST)
Time frame: Day 0
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation.
Number of Participants With Sub Acute Scaffold Thrombosis (ST)
Time frame: >1 to 30 days
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation.
Number of Participants With Late Scaffold Thrombosis (ST)
Time frame: 31 to 90 days
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation.
Number of Participants With Late Scaffold Thrombosis (ST)
Time frame: 31 to 365 days
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation.
Number of Participants With Very Late Scaffold Thrombosis (ST)
Time frame: 366 to 730 days
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation.
Number of Participants With Overall Scaffold Thrombosis (ST)
Time frame: 0 to 90 days
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Number of Participants With Cumulative Scaffold Thrombosis
Time frame: 0 to 90 days
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Number of Participants With Cumulative Scaffold Thrombosis
Time frame: 0 to 730 days
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Number of Participants With Exclusion of Very Small Vessels
Time frame: During index procedure, "54.8 ± 27.6 min"
For Phase 1 patients, Angiograms and IVUS/OCT images taken during procedure will be sent immediately to the core lab. Additional training or revision of registration criteria may occur as required in order to exclude almost all lesions with RVD < 2.5 mm from registration by the last half of Phase 1.
Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging
Time frame: During index procedure, "54.8 ± 27.6 min"
IVUS/OCT images taken during procedure will be sent immediately to the core lab, which will analyze the images and give feedback to the site as required. Images of ST, if occurred, will also be sent to the core lab.
Number of Participants With Composite of Device Deficiencies
Time frame: During index procedure, "54.8 ± 27.6 min"
Device deficiencies: Number of participants with at least one of the following Device deficiencies 1. Lesion/implant failure 2. Delivery difficulty (finally delivered) 3. Re-crossing failure 4. Re-crossing difficulty 5. Post-dilatation balloon 6. Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS) 7. Instruction for Use (IFU) not included 8. Major Strut Malapposition 9. Strut Fracture within 6 months
Number of Participants With Late Scaffold Thrombosis (ST)
Time frame: 731 - 1095 days
Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation.
Number of Participants With Cumulative Scaffold Thrombosis
Time frame: 0 - 1095 days
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Number of Participants With Very Late Scaffold Thrombosis (ST)
Time frame: 1096 - 1460 days
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Number of Participants With Cumulative Scaffold Thrombosis
Time frame: 0 - 1460 days
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Number of Participants With Cumulative Scaffold Thrombosis
Time frame: 0 - 1825 days
Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation.

85 secondary outcomes

Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Time frame: 0 to 30 days
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Time frame: 0 to 90 days
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Time frame: 0 to 1 year
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Time frame: 0 to 2 years
Number of Participants With All Myocardial Infarction (MI)
Time frame: 0 to 30 days
Number of Participants With All Myocardial Infarction (MI)
Time frame: 0 to 90 days
Number of Participants With All Myocardial Infarction (MI)
Time frame: 0 to 1 year
Number of Participants With All Myocardial Infarction (MI)
Time frame: 0 to 2 years
Number of Participants With All Target Lesion Revascularization (TLR)
Time frame: 0 to 30 days
Number of Participants With All Target Lesion Revascularization (TLR)
Time frame: 0 to 90 days
Number of Participants With All Target Lesion Revascularization (TLR)
Time frame: 0 to 1 year
Number of Participants With All Target Lesion Revascularization (TLR)
Time frame: 0 to 2 years
Number of Participants With All Target Vessel Revascularization (TVR)
Time frame: 0 to 30 days
Number of Participants With All Target Vessel Revascularization (TVR)
Time frame: 0 to 90 days
Number of Participants With All Target Vessel Revascularization (TVR)
Time frame: 0 to 1 year
Number of Participants With All Target Vessel Revascularization (TVR)
Time frame: 0 to 2 years
Number of Participants With All Coronary Revascularization
Time frame: 0 to 30 days
Number of Participants With All Coronary Revascularization
Time frame: 0 to 90 days
Number of Participants With All Coronary Revascularization
Time frame: 0 to 1 year
Number of Participants With All Coronary Revascularization
Time frame: 0 to 2 years
Number of Death/MI/All Revascularization (DMR)
Time frame: 0 to 30 days
Number of Death/MI/All Revascularization (DMR)
Time frame: 0 to 90 days
Number of Death/MI/All Revascularization (DMR)
Time frame: 0 to 1 year
Number of Death/MI/All Revascularization (DMR)
Time frame: 0 to 2 years
Number of Participants With Target Vessel Failure (TVF)
Time frame: 0 to 30 days
Number of Participants With Target Vessel Failure (TVF)
Time frame: 0 to 90 days
Number of Participants With Target Vessel Failure (TVF)
Time frame: 0 to 1 Year
Number of Participants With Target Vessel Failure (TVF)
Time frame: 0 to 2 years
Number of Major Adverse Cardiac Event (MACE)
Time frame: 0 to 30 days
Number of Major Adverse Cardiac Event (MACE)
Time frame: 0 to 90 days
Number of Major Adverse Cardiac Event (MACE)
Time frame: 0 to 1 year
Number of Major Adverse Cardiac Event (MACE)
Time frame: 0 to 2 years
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Time frame: 0 to 30 days
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Time frame: 0 to 90 days
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Time frame: 0 to 1 year
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Time frame: 0 to 2 years
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Time frame: 0 to 30 days
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Time frame: 0 to 90 days
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Time frame: 0 to 1 year
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Time frame: 0 to 2 years

Results and safety

Results posted to the registry on 3 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Absorb GT1 BVS	135	114

Primary outcome: Number of Participants With Acute Scaffold Thrombosis (ST)

Time frame: Day 0. Number. Unit: participants

Measure	Absorb GT1 BVS n = 134
Definite	0
Probable	0
Definite/Probable	0

Population analysed: Full Analysis Set (all participants with Absorb GT1)

Primary outcome: Number of Participants With Sub Acute Scaffold Thrombosis (ST)

Time frame: >1 to 30 days. Number. Unit: participants

Measure	Absorb GT1 BVS n = 134
Definite	0
Probable	0
Definite/Probable	0

Population analysed: Full Analysis Set (all participants with Absorb GT1)

Primary outcome: Number of Participants With Late Scaffold Thrombosis (ST)

Time frame: 31 to 90 days. Number. Unit: participants

Measure	Absorb GT1 BVS n = 134
Definite	0
Probable	0
Definite/Probable	0

Population analysed: Full Analysis Set (all participants with Absorb GT1)

Primary outcome: Number of Participants With Late Scaffold Thrombosis (ST)

Time frame: 31 to 365 days. Number. Unit: participants

Measure	Absorb GT1 BVS n = 134
Definite	0
Probable	0
Definite/Probable	0

Population analysed: Full Analysis Set (all participants with Absorb GT1)

85 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 Years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Absorb GT1 BVS	43 of 135 (31.9%)	8 of 135 (5.9%)	4 of 135

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38479861Nakamura M, Suzuki N, Fujii K, Furuya J, Kawasaki T, Kimura T, Sakamoto T, Tanabe K, Kusano H, Stockelman KA, Kozuma K. The Absorb GT1 Bioresorbable Vascular Scaffold System - 5-Year Post-Market Surveillance Study in Japan. Circ J. 2024 May 24;88(6):863-872. doi: 10.1253/circj.CJ-23-0877. Epub 2024 Mar 13.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Masato Nakamura, MD principal investigator

Toho University Ohashi Medical Hospital

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ABSORB GT1 BVS in people with Ischemic Heart Disease and Angina Pectoris, run by Abbott Medical Devices at 15 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Acute Scaffold Thrombosis (ST) (time frame: Day 0). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03409731, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.