Coronary Artery DiseaseAbsorbISRNCT02474485
Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR
A study testing BVS Absorb implantation., DEB Sequent Please inflation. and OCT visualization. in people with Coronary Artery Disease and Coronary Restenosis, run by SIS Medical AG at 1 site in Switzerland.
Trial summary
AbsorbISR is a randomized, controlled trial, single center, prospective, not blinded to evaluate two strategies of in stent restenosis treatment: Implantation of drug eluting bioresorbable stent scaffold Absorb® vs. balloon angioplasty with drug eluting balloon Sequent Please®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Restenosis
- What is being tested?
- BVS Absorb implantation., DEB Sequent Please inflation. and OCT visualization.
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2015to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Diagnosed with ISR requiring percutaneous coronary intervention: visual diameter stenosis > 70 % and/or Fractional Flow Reserve < 0.81 and/or non-invasive testing demonstrating ischemia. This real-life population with in-stent restenosis beside typical stable patients with ISR includes ACS patients with thrombus containing lesions, patients with multivessel disease, patients with ISR in non-infarct related artery, with ISR in bare metal stent (BMS), drug eluting stent (DES) or bioresorbable vascular scaffold (BVS), ISR in lesion previously treated by plain old balloon angioplasty (POBA), drug eluting balloon (DEB) or additional stent implantation.
- Double anti-platelet therapy for the duration of at least 12 months is considered possible at the time of intervention
Who cannot join
- The participant may not enter the study if the interventionist has doubts that he is not able to deliver and implant the Absorb scaffold (e.g. highly calcified lesions).
- Patients who have any contraindications for using DEB (SeQent Please) or BVS (Absorb) specified in instructions for use are not able to participate in this study.
- Women with childbearing potential must have a negative result of pregnancy test and they must use an effective contraception method for at least 12 months after study procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis
AbsorbISR is a randomized, controlled trial, single center, prospective, not blinded to evaluate two strategies of in stent restenosis treatment: Implantation of drug eluting bioresorbable stent scaffold Absorb® vs. balloon angioplasty with drug eluting balloon Sequent Please®.
Read the detailed description
This is randomized-controlled trial of Absorb® Bioresorbable Vascular Scaffold (BVS) vs. Sequent Please® drug coated balloon in an all-comers population with in-stent-restenosis (ISR). The patients will be randomized in a 1:1 fashion and the investigators intend to include 150 patients.
All patients presenting with ISR and requiring percutaneous coronary intervention will be eligible to be included in this study. This will include patients with stable angina and those presenting with acute coronary syndrome (ACS).
The primary objective of this study is to demonstrate superiority of the Absorb® bioresorbable scaffold compared to the Sequent Please® Drug Coated Balloon when treating patients with In-Stent-Restenosis regards to primary endpoint - angiographic late lumen loss at 9 month follow-up.
- Conditions
- Coronary Artery Disease, Coronary Restenosis
- Being tested
- BVS Absorb implantation., DEB Sequent Please inflation., Control coronary angiography., OCT visualization., Clinical observation.
- Keywords
- bioresorbable vascular scaffold, Absorb, drug eluting balloon, percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease, Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BVS Absorb implantation.Device
Absorb bioresorbable vascular scaffold will be implanted to treat in stent restenosis in target vessel.
DEB Sequent Please inflation.Device
Inflation of drug eluting balloon Sequent Please will be performed to treat in stent restenosis in target vessel.
Control coronary angiography.Procedure or surgery
Control coronary angiography will be performed at 9 month follow-up.
OCT visualization.Procedure or surgery
OCT visualization will be performed during index procedure and at 9 month follow-up.
Clinical observation.Other
Patients will be informed that Investigator will contact them at 12, 24 and 60 months after the procedure. Investigator will collect information regarding clinical status of Patients, cardiac medications and any adverse events that occurred since the last follow-up.
| Study group | Role | What they receive |
|---|---|---|
| BVS - Absorb | Active comparator | BVS - Absorb scaffold group will be treated by implantation of drug eluting bioresorbable vascular scaffold (Absorb®). In this arm following interventions will be performed:
* BVS Absorb implantation. For in stent restenosis treatment during index procedure.
* OCT visualization.During index procedure and at 9 month follow-up.
* Control coronary angiography. Control angiography will be performed at 9 month follow-up.
* Clinical observation. Clinical observation will be performed at 9, 12 and 60 month follow-up. Receives: Device: BVS Absorb implantation.; Procedure: Control coronary angiography.; Procedure: OCT visualization.; Other: Clinical observation. |
| DEB - Sequent Please | Active comparator | In DEB - Sequent Please Group, dilatation of drug eluting balloon Sequent Please ® will be used for treatment of the narrowed part of the artery. In this arm following interventions will be performed:
* DEB Sequent Please inflation. For in stent restenosis treatment during index procedure.
* OCT visualization.During index procedure and at 9 month follow-up.
* Control coronary angiography. Control angiography will be performed at 9 month follow-up.
* Clinical observation. Clinical observation will be performed at 9, 12 and 60 month follow-up. Receives: Device: DEB Sequent Please inflation.; Procedure: Control coronary angiography.; Procedure: OCT visualization.; Other: Clinical observation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic late lumen loss at 9 month follow-up.
Angiographic late lumen loss will be compared between both study groups.
Measured: At 9 month follow up.
Secondary outcomes (18)
Incidence of periprocedural complications: unplanned use of GP IIb/IIIa inhibitors.
Measured: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of periprocedural complications: vessel rupture.
Measured: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of periprocedural complications: side branch occlusion.
Measured: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of periprocedural complications: peri-procedural myocardial infarction.
Measured: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Comparison of minimal luminal diameter between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm)).
Measured: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Comparison of diameter stenosis between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm)).
Measured: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Comparison of rate of restenosis between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm)).
Measured: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of in-stent-restenosis in long-term observation.
Measured: During 60 month follow-up.
Incidence of target lesion failure in long-term observation.
Measured: During 60 month follow-up.
Incidence of target vessel revascularisation in long-term observation.
Measured: During 60 month follow-up.
Incidence of stent thrombosis in long-term observation.
Measured: During 60 month follow-up.
Occurence of stent thrombosis (defined as early, late and very late probable or definite according to ARC definition).
Measured: During 60 month follow-up.
Cardiac and non-cardiac death in both groups.
Measured: During 60 month follow-up.
Assessment of possibility vessel measurement and stent diameter/length choice based on these measurement in optical coherence tomography (OCT).
Measured: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Result of index procedure assessment in OCT post procedure (lumen/stent area, struts assessment, dissections, stent expansion).
Measured: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
OCT assessment of long-term study results (lumen/stent area, struts assessment, neointimal volume, lumen volume).
Measured: At 9 month follow-up.
Lumen volume change between index and 9 month follow-up OCT.
Measured: OCT parameters change will be assessed between index hospitalization and 9 month follow-up.
Minimal lumen area change between index and 9 month follow-up OCT.
Measured: OCT parameters change will be assessed between index hospitalization and 9 month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2018 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: Information of other studies with Abseb bioresorbable scaffolds showed a higher thrombotic risk than before, the risk for the Patients is estimated too high
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- SIS Medical AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Florim Cuculi, Prof. dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474485
- Sponsor's protocol ID
- AbsorbISR
- Acronym
- AbsorbISR
- Status last verified
- Mar 2018
- First submitted
- 11 Jun 2015
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis
- ClinicalTrials.gov ID
- NCT02474485
- Acronym / sponsor ID
- AbsorbISR / AbsorbISR
- Conditions
- Coronary Artery Disease, Coronary Restenosis
- Keywords
- bioresorbable vascular scaffold, Absorb, drug eluting balloon, percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Information of other studies with Abseb bioresorbable scaffolds showed a higher thrombotic risk than before, the risk for the Patients is estimated too high
- Enrolment
- 53 participants (actual)
- Lead sponsor
- SIS Medical AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 17 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AbsorbISR is a randomized, controlled trial, single center, prospective, not blinded to evaluate two strategies of in stent restenosis treatment: Implantation of drug eluting bioresorbable stent scaffold Absorb® vs. balloon angioplasty with drug eluting balloon Sequent Please®.
Detailed description
This is randomized-controlled trial of Absorb® Bioresorbable Vascular Scaffold (BVS) vs. Sequent Please® drug coated balloon in an all-comers population with in-stent-restenosis (ISR). The patients will be randomized in a 1:1 fashion and the investigators intend to include 150 patients.
All patients presenting with ISR and requiring percutaneous coronary intervention will be eligible to be included in this study. This will include patients with stable angina and those presenting with acute coronary syndrome (ACS).
The primary objective of this study is to demonstrate superiority of the Absorb® bioresorbable scaffold compared to the Sequent Please® Drug Coated Balloon when treating patients with In-Stent-Restenosis regards to primary endpoint - angiographic late lumen loss at 9 month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BVS - Absorb | Active comparator | Device: BVS Absorb implantation., Procedure: Control coronary angiography., Procedure: OCT visualization., Other: Clinical observation.BVS - Absorb scaffold group will be treated by implantation of drug eluting bioresorbable vascular scaffold (Absorb®). In this arm following interventions will be performed: * BVS Absorb implantation. For in stent restenosis treatment during index procedure. * OCT visualization.During index procedure and at 9 month follow-up. * Control coronary angiography. Control angiography will be performed at 9 month follow-up. * Clinical observation. Clinical observation will be performed at 9, 12 and 60 month follow-up. |
| DEB - Sequent Please | Active comparator | Device: DEB Sequent Please inflation., Procedure: Control coronary angiography., Procedure: OCT visualization., Other: Clinical observation.In DEB - Sequent Please Group, dilatation of drug eluting balloon Sequent Please ® will be used for treatment of the narrowed part of the artery. In this arm following interventions will be performed: * DEB Sequent Please inflation. For in stent restenosis treatment during index procedure. * OCT visualization.During index procedure and at 9 month follow-up. * Control coronary angiography. Control angiography will be performed at 9 month follow-up. * Clinical observation. Clinical observation will be performed at 9, 12 and 60 month follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Diagnosed with ISR requiring percutaneous coronary intervention: visual diameter stenosis > 70 % and/or Fractional Flow Reserve < 0.81 and/or non-invasive testing demonstrating ischemia. This real-life population with in-stent restenosis beside typical stable patients with ISR includes ACS patients with thrombus containing lesions, patients with multivessel disease, patients with ISR in non-infarct related artery, with ISR in bare metal stent (BMS), drug eluting stent (DES) or bioresorbable vascular scaffold (BVS), ISR in lesion previously treated by plain old balloon angioplasty (POBA), drug eluting balloon (DEB) or additional stent implantation.
- Double anti-platelet therapy for the duration of at least 12 months is considered possible at the time of intervention
Key exclusion criteria (3 listed)
- The participant may not enter the study if the interventionist has doubts that he is not able to deliver and implant the Absorb scaffold (e.g. highly calcified lesions).
- Patients who have any contraindications for using DEB (SeQent Please) or BVS (Absorb) specified in instructions for use are not able to participate in this study.
- Women with childbearing potential must have a negative result of pregnancy test and they must use an effective contraception method for at least 12 months after study procedure.
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 |
|---|---|---|
| BVS Absorb implantation.Absorb bioresorbable vascular scaffold will be implanted to treat in stent restenosis in target vessel. | Device | BVS - Absorb |
| DEB Sequent Please inflation.Inflation of drug eluting balloon Sequent Please will be performed to treat in stent restenosis in target vessel. | Device | DEB - Sequent Please |
| Control coronary angiography.Control coronary angiography will be performed at 9 month follow-up. | Procedure or surgery | BVS - Absorb, DEB - Sequent Please |
| OCT visualization.OCT visualization will be performed during index procedure and at 9 month follow-up. | Procedure or surgery | BVS - Absorb, DEB - Sequent Please |
| Clinical observation.Patients will be informed that Investigator will contact them at 12, 24 and 60 months after the procedure. Investigator will collect information regarding clinical status of Patients, cardiac medications and any adverse events that occurred since the last follow-up. | Other | BVS - Absorb, DEB - Sequent Please |
Primary outcome
Angiographic late lumen loss at 9 month follow-up.
Time frame: At 9 month follow up.
Angiographic late lumen loss will be compared between both study groups.
18 secondary outcomes
Incidence of periprocedural complications: unplanned use of GP IIb/IIIa inhibitors.
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of periprocedural complications: vessel rupture.
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of periprocedural complications: side branch occlusion.
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of periprocedural complications: peri-procedural myocardial infarction.
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Comparison of minimal luminal diameter between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm)).
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Comparison of diameter stenosis between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm)).
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Comparison of rate of restenosis between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm)).
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of in-stent-restenosis in long-term observation.
Time frame: During 60 month follow-up.
Incidence of target lesion failure in long-term observation.
Time frame: During 60 month follow-up.
Incidence of target vessel revascularisation in long-term observation.
Time frame: During 60 month follow-up.
Incidence of stent thrombosis in long-term observation.
Time frame: During 60 month follow-up.
Occurence of stent thrombosis (defined as early, late and very late probable or definite according to ARC definition).
Time frame: During 60 month follow-up.
Cardiac and non-cardiac death in both groups.
Time frame: During 60 month follow-up.
Assessment of possibility vessel measurement and stent diameter/length choice based on these measurement in optical coherence tomography (OCT).
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Result of index procedure assessment in OCT post procedure (lumen/stent area, struts assessment, dissections, stent expansion).
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
OCT assessment of long-term study results (lumen/stent area, struts assessment, neointimal volume, lumen volume).
Time frame: At 9 month follow-up.
Lumen volume change between index and 9 month follow-up OCT.
Time frame: OCT parameters change will be assessed between index hospitalization and 9 month follow-up.
Minimal lumen area change between index and 9 month follow-up OCT.
Time frame: OCT parameters change will be assessed between index hospitalization and 9 month follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
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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.
Florim Cuculi, Prof. dr principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BVS Absorb implantation., DEB Sequent Please inflation. and OCT visualization. in people with Coronary Artery Disease and Coronary Restenosis, run by SIS Medical AG at 1 site in Switzerland.
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 4 inclusion and 3 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: paused, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Results are not available in the source record.
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?
Angiographic late lumen loss at 9 month follow-up. (time frame: At 9 month follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2018.