Coronary Artery Disease (CAD)EXPERT CTONCT01435031

EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions

A study testing CTO Treatment Device in people with Coronary Artery Disease (CAD) and Chronic Total Occlusion (CTO), run by Abbott Medical Devices at 1 site in United States.

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

A prospective, multi-center, single-arm study to establish the safety and effectiveness of the XIENCE V® Everolimus Eluting Coronary Stent, XIENCE nano™ Everolimus Eluting Coronary Stent, XIENCE PRIME™ LL Everolimus Eluting Coronary Stent, HT PROGRESS and HT PILOT Coronary Guide Wires, and MINI-TREK Coronary… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease (CAD), Chronic Total Occlusion (CTO)
What is being tested?: CTO Treatment Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 250 participants
Where: 1 siteUnited States
Study dates: Sep 2011to Dec 2017
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

The lesion is located in a native vessel distal to anastomosis with a graft.
The vessel has other lesions with greater than 40% diameter stenosis based on visual estimate or on-line QCA.
The vessel has evidence of thrombus.
The vessel is excessively tortuous.
The lesion has any of the following characteristics:
Lesion location is aorto-ostial, an unprotected left main lesion, or within 5 mm of the origin of the left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX), or right coronary artery (RCA).

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Involves a side branch > 2.0 mm in diameter.
Is at or distal to a > 45º bend in the vessel.
Is moderately to severely calcified.
TIMI flow 0 or 1.

Trial locations and contacts

1 site in 1 country.

United States1 site

Abbott Vascular
Santa Clara, California, 95054

Other trials in United States

About this study

Official title: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions

Conditions: Coronary Artery Disease (CAD), Chronic Total Occlusion (CTO)
Being tested: CTO Treatment Device
Keywords: Angioplasty, Chronic Total Occlusion (CTO), Chronic total coronary occlusions, Coronary Artery Disease (CAD), Coronary artery stenosis, Total coronary occlusion
Medical subject headings: Coronary Artery Disease, Coronary Stenosis

What participants receive

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

CTO Treatment DeviceDevice
Subjects receiving at least 1 of the following for the treatment of CTO:
- XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
- HT PROGRESS and/or HT PILOT guide wires in recanalization
- MINI-TREK Coronary Dilatation Catheter in predilatation

Study groups in NCT01435031
Study group	Role	What they receive
CTO Treatment	Other	Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation Receives: Device: CTO Treatment Device

What is being measured

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

Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)
The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.
Measured: 1 year
Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set)
The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.
Measured: 1 year
Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI)
Successful recanalization of the CTO defined as:
1. Confirmation of placement of the guide wire in the distal true lumen (component 1)
2. Absence of in-hospital MACE, based on ARC MI (component 2)
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI)
Successful recanalization of the CTO defined as:
1. Confirmation of placement of the guide wire in the distal true lumen (component 1)
2. Absence of in-hospital MACE, based on protocol MI (component 2)
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Angioplasty Predilatation-related: Successful Predilatation of the CTO
1. Successful delivery of the MINI-TREK Coronary Dilatation Catheter to and across the target lesion and;
2. Successful inflation and deflation of the MINI-TREK Coronary Dilatation Catheter and;
3. Absence of clinically significant vessel perforation, flow-limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) from baseline or clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with MINI-TREK and;
4. Achievement of final TIMI flow 3 for the target lesion at the conclusion of the index procedure
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Secondary outcomes (90)

Minimum Lumen Diameter (MLD): Pre-procedure
Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.
MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during Quantitative coronary angiography (QCA) by the Angiographic Core Laboratory.
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Minimum Lumen Diameter (MLD): Post-procedure
Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.
MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Laboratory.
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure
Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.
TIMI Classification:
TIMI 0 No perfusion.
TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run.
TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.
TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds.
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Change in TIMI Flow Grade: Post-procedure
Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.
TIMI Classification:
TIMI 0 No perfusion.
TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run.
TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.
TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds.
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Device Success
Achievement of <50% diameter stenosis within the target lesion segment using assigned study device
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedure Success
Device success and absence of in-hospital MACE.
Per-protocol MI definition: Myocardial infarctions per protocol definition were categorized as Q-wave (development of new, pathological Q waves on the ECG) or non-Q-wave (elevation of CK levels to greater than two times the upper limit of normal and elevated CK-MB in the absence of new pathological Q waves).
Per ARC MI definition: Myocardial infarctions per ARC definition were also categorized as Q-wave (development of new pathological Q waves in 2 or more contiguous leads (according to the Minnesota code) with or without post-procedure CK or CK-MB levels elevated above normal) or non-Q-wave (all MIs not classified as Q-wave). ARC defined MIs were further classified as Periprocedural PCI, Periprocedural CABG, Spontaneous, Sudden Death, and Reinfarction based on biomarker and additional criteria and as ST Elevation MI (STEMI) or Non-ST Elevation MI (NSTEMI) based on ST segment.
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Antegrade Crossing
Defined as device success and absence of in-hospital MACE with antegrade crossing technique.
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Subintimal Tracking and Re-entry (STAR) Technique
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Knuckle Wire
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Primary Retrograde Wire Crossing
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Controlled Antegrade-Retrograde Technique (CART)
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Reverse CART
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Kissing Wire Technique
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Sub Intimal Technique
Defined as device success and absence of in-hospital MACE with antegrade crossing technique.
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Multiple Crossing Techniques
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Resource Utilization: Procedural Time
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Resource Utilization: Fluoroscopic Time
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Resource Utilization: Contrast Volume
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Clinically Significant Perforation
Any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft or comparable therapy
Measured: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Measured: 30 days
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Measured: 6 months
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Measured: 1 year
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Measured: 2 years
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Measured: 3 years
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Measured: 4 years
Number of Participants Experiencing Death
MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
1. Acute MI
2. Cardiac perforation/pericardial tamponade
3. Arrhythmia or conduction abnormality
4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
6. Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 30 days
Number of Participants Experiencing Death
MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
1. Acute MI
2. Cardiac perforation/pericardial tamponade
3. Arrhythmia or conduction abnormality
4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
6. Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 6 months
Number of Participants Experiencing Death
MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
1. Acute MI
2. Cardiac perforation/pericardial tamponade
3. Arrhythmia or conduction abnormality
4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
6. Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 1 year
Number of Participants Experiencing Death
MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
1. Acute MI
2. Cardiac perforation/pericardial tamponade
3. Arrhythmia or conduction abnormality
4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
6. Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 2 years
Number of Participants Experiencing Death
MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
1. Acute MI
2. Cardiac perforation/pericardial tamponade
3. Arrhythmia or conduction abnormality
4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
6. Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 3 years
Number of Participants Experiencing Death
MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
1. Acute MI
2. Cardiac perforation/pericardial tamponade
3. Arrhythmia or conduction abnormality
4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
6. Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 4 years
Number of Participants Experiencing Cardiac Death
TLF component.
Cardiac death was defined as death due to any of the following:
1. Acute MI
2. Cardiac perforation/pericardial tamponade
3. Arrhythmia or conduction abnormality
4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
6. Any death in which a cardiac cause cannot be excluded
Measured: 30 days
Number of Participants Experiencing Cardiac Death
TLF component.
Cardiac death was defined as death due to any of the following:
1. Acute MI
2. Cardiac perforation/pericardial tamponade
3. Arrhythmia or conduction abnormality
4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
6. Any death in which a cardiac cause cannot be excluded
Measured: 6 months
Number of Participants Experiencing Cardiac Death
TLF component.
Cardiac death was defined as death due to any of the following:
1. Acute MI
2. Cardiac perforation/pericardial tamponade
3. Arrhythmia or conduction abnormality
4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
6. Any death in which a cardiac cause cannot be excluded
Measured: 1 year
Number of Participants Experiencing Cardiac Death
TLF component.
Cardiac death was defined as death due to any of the following:
1. Acute MI
2. Cardiac perforation/pericardial tamponade
3. Arrhythmia or conduction abnormality
4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
6. Any death in which a cardiac cause cannot be excluded
Measured: 2 years
Number of Participants Experiencing Cardiac Death
TLF component.
Cardiac death was defined as death due to any of the following:
1. Acute MI
2. Cardiac perforation/pericardial tamponade
3. Arrhythmia or conduction abnormality
4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
6. Any death in which a cardiac cause cannot be excluded
Measured: 3 years
Number of Participants Experiencing Cardiac Death
TLF component.
Cardiac death was defined as death due to any of the following:
1. Acute MI
2. Cardiac perforation/pericardial tamponade
3. Arrhythmia or conduction abnormality
4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
6. Any death in which a cardiac cause cannot be excluded
Measured: 4 years
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component;
Myocardial Infarction (per ARC definition)
- Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
- Non-Q-wave MI: All MIs not classified as Q-wave.
Measured: 30 days
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component;
Myocardial Infarction (per ARC definition)
- Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
- Non-Q-wave MI: All MIs not classified as Q-wave.
Measured: 6 months
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component;
Myocardial Infarction (per ARC definition)
- Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
- Non-Q-wave MI: All MIs not classified as Q-wave.
Measured: 1 year
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component;
Myocardial Infarction (per ARC definition)
- Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
- Non-Q-wave MI: All MIs not classified as Q-wave.
Measured: 2 years
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component;
Myocardial Infarction (per ARC definition)
- Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
- Non-Q-wave MI: All MIs not classified as Q-wave.
Measured: 3 years
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component;
Myocardial Infarction (per ARC definition)
- Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
- Non-Q-wave MI: All MIs not classified as Q-wave.
Measured: 4 years
Number of Participants With Target Vessel-related MI
TLF Component; per ARC
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Measured: 30 days
Number of Participants With Target Vessel-related MI
TLF Component; per ARC
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Measured: 6 months
Number of Participants With Target Vessel-related MI
TLF Component; per ARC
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Measured: 1 year
Number of Participants With Target Vessel-related MI
TLF Component; per ARC
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Measured: 2 years
Number of Participants With Target Vessel-related MI
TLF Component; per ARC
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Measured: 3 years
Number of Participants With Target Vessel-related MI
TLF Component; per ARC
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Measured: 4 years
Number of Participants With Target Lesion Revascularization (TLR)
Repeat percutaneous coronary intervention (PCI) or Coronary artery bypass graft (CABG) to the target lesion/site.
Measured: 30 days
Number of Participants With Target Lesion Revascularization (TLR)
Repeat PCI or CABG to the target lesion/site.
Measured: 6 months
Number of Participants With Target Lesion Revascularization (TLR)
Repeat PCI or CABG to the target lesion/site.
Measured: 1 year
Number of Participants With Target Lesion Revascularization (TLR)
Repeat PCI or CABG to the target lesion/site.
Measured: 2 years
Number of Participants With Target Lesion Revascularization (TLR)
Repeat PCI or CABG to the target lesion/site.
Measured: 3 years
Number of Participants With Target Lesion Revascularization (TLR)
Repeat PCI or CABG to the target lesion/site.
Measured: 4 years
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.
Measured: 30 days
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.
Measured: 6 months
Number of Participants With Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.
Measured: 1 year
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.
Measured: 2 years
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.
Measured: 3 years
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.
Measured: 4 years
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel. Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study
Measured: 30 days
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel.
Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study
Measured: 6 months
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel.
Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study
Measured: 1 year
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel.
Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study
Measured: 2 years
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel.
Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study
Measured: 3 years
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel.
Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study
Measured: 4 years
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when any of the following events occur:
- Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
- Cardiac death not clearly due to a non-target vessel endpoint.
- Target vessel revascularization is determined.
Measured: 30 days
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when ANY of the following events occur:
- Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
- Cardiac death not clearly due to a non-target vessel endpoint.
- Target vessel revascularization is determined.
Measured: 6 months
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when ANY of the following events occur:
- Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
- Cardiac death not clearly due to a non-target vessel endpoint.
- Target vessel revascularization is determined.
Measured: 1 year
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when ANY of the following events occur:
- Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
- Cardiac death not clearly due to a non-target vessel endpoint.
- Target vessel revascularization is determined.
Measured: 2 years
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when ANY of the following events occur:
- Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
- Cardiac death not clearly due to a non-target vessel endpoint.
- Target vessel revascularization is determined.
Measured: 3 years
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when ANY of the following events occur:
- Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
- Cardiac death not clearly due to a non-target vessel endpoint.
- Target vessel revascularization is determined.
Measured: 4 years
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.
Measured: 30 days
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.
Measured: 6 months
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.
Measured: 1 year
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR
Measured: 2 years
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR
Measured: 3 years
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR
Measured: 4 years
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria; definite and probable
Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Measured: Acute (0-24 hours)
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria; definite and probable. Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Measured: Subacute (>24 hours to 30 days)
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria; definite and probable.
Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Measured: Late (>30 days to 1 year)
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria; definite and probable.
Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Measured: 1 year
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria.
Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Measured: 2 years
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria.
Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Measured: 3 years
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria.
Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Measured: 4 years
Number of Participants With Occurrence of Stent Fracture at Target Lesion
Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.
Measured: 1 year
Number of Participants With Occurrence of Stent Fracture at Target Lesion
Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.
Measured: 2 years
Number of Participants With Occurrence of Stent Fracture at Target Lesion
Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.
Measured: 3 years
Number of Participants With Occurrence of Stent Fracture at Target Lesion
Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.
Measured: 4 years

Timeline

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

Sep 2011Dec 2017

First posted15 Sep 2011 (estimated)
Study startSep 2011
Primary completionFeb 2014
Study completionDec 2017

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 Coronary Artery Disease (CAD)Studies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01435031
Sponsor's protocol ID: 11-394
Acronym: EXPERT CTO
Status last verified: Feb 2018
First submitted: 13 Sep 2011
Last updated: 9 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kandzari DE, Kini AS, Karmpaliotis D, Moses JW, Tummala PE, Grantham JA, Orr C, Lombardi W, Nicholson WJ, Lembo NJ, Popma JJ, Wang J, Larracas C, Rutledge DR. Safety and Effectiveness of Everolimus-Eluting Stents in Chronic Total Coronary Occlusion Revascularization: Results From the EXPERT CTO Multicenter Trial (Evaluation of the XIENCE Coronary Stent, Performance, and Technique in Chronic Total Occlusions). JACC Cardiovasc Interv. 2015 May;8(6):761-769. doi: 10.1016/j.jcin.2014.12.238. Epub 2015 Apr 22.
PubMed 25912400

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?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Coronary Artery Disease (CAD) trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions
ClinicalTrials.gov ID: NCT01435031
Acronym / sponsor ID: EXPERT CTO / 11-394
Conditions: Coronary Artery Disease (CAD), Chronic Total Occlusion (CTO)
Keywords: Angioplasty, Chronic Total Occlusion (CTO), Chronic total coronary occlusions, Coronary Artery Disease (CAD), Coronary artery stenosis, Total coronary occlusion
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Feb 2014 (actual)
Study completion: Dec 2017 (actual)
First posted: 15 Sep 2011 (estimated)
Results: Posted 25 Nov 2014

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

Arm	Type	Receives
CTO Treatment	Other	Device: CTO Treatment DeviceSubjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (10 listed)

The lesion is located in a native vessel distal to anastomosis with a graft.
The vessel has other lesions with greater than 40% diameter stenosis based on visual estimate or on-line QCA.
The vessel has evidence of thrombus.
The vessel is excessively tortuous.
The lesion has any of the following characteristics:

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
CTO Treatment DeviceSubjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation	Device	CTO Treatment

Primary outcome

Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)
Time frame: 1 year
The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.
Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set)
Time frame: 1 year
The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.
Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI)
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Successful recanalization of the CTO defined as: 1. Confirmation of placement of the guide wire in the distal true lumen (component 1) 2. Absence of in-hospital MACE, based on ARC MI (component 2)
Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI)
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Successful recanalization of the CTO defined as: 1. Confirmation of placement of the guide wire in the distal true lumen (component 1) 2. Absence of in-hospital MACE, based on protocol MI (component 2)
Percentage of Participants With Angioplasty Predilatation-related: Successful Predilatation of the CTO
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
1. Successful delivery of the MINI-TREK Coronary Dilatation Catheter to and across the target lesion and; 2. Successful inflation and deflation of the MINI-TREK Coronary Dilatation Catheter and; 3. Absence of clinically significant vessel perforation, flow-limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) from baseline or clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with MINI-TREK and; 4. Achievement of final TIMI flow 3 for the target lesion at the conclusion of the index procedure

90 secondary outcomes

Minimum Lumen Diameter (MLD): Pre-procedure
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Minimum Lumen Diameter (MLD): Post-procedure
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Change in TIMI Flow Grade: Post-procedure
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Device Success
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedure Success
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Antegrade Crossing
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Subintimal Tracking and Re-entry (STAR) Technique
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Knuckle Wire
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Primary Retrograde Wire Crossing
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Controlled Antegrade-Retrograde Technique (CART)
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Reverse CART
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Kissing Wire Technique
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Sub Intimal Technique
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Procedural Success With Multiple Crossing Techniques
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Resource Utilization: Procedural Time
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Resource Utilization: Fluoroscopic Time
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Resource Utilization: Contrast Volume
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Clinically Significant Perforation
Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Number of Participants With Major Adverse Cardiac Events (MACE)
Time frame: 30 days
Number of Participants With Major Adverse Cardiac Events (MACE)
Time frame: 6 months
Number of Participants With Major Adverse Cardiac Events (MACE)
Time frame: 1 year
Number of Participants With Major Adverse Cardiac Events (MACE)
Time frame: 2 years
Number of Participants With Major Adverse Cardiac Events (MACE)
Time frame: 3 years
Number of Participants With Major Adverse Cardiac Events (MACE)
Time frame: 4 years
Number of Participants Experiencing Death
Time frame: 30 days
Number of Participants Experiencing Death
Time frame: 6 months
Number of Participants Experiencing Death
Time frame: 1 year
Number of Participants Experiencing Death
Time frame: 2 years
Number of Participants Experiencing Death
Time frame: 3 years
Number of Participants Experiencing Death
Time frame: 4 years
Number of Participants Experiencing Cardiac Death
Time frame: 30 days
Number of Participants Experiencing Cardiac Death
Time frame: 6 months
Number of Participants Experiencing Cardiac Death
Time frame: 1 year
Number of Participants Experiencing Cardiac Death
Time frame: 2 years
Number of Participants Experiencing Cardiac Death
Time frame: 3 years
Number of Participants Experiencing Cardiac Death
Time frame: 4 years
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
Time frame: 30 days
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
Time frame: 6 months
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
Time frame: 1 year

Results and safety

Results posted to the registry on 25 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CTO Treatment	222	216

Primary outcome: Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)

Time frame: 1 year. Count of participants. Unit: Participants

Measure	CTO Treatment n = 211
Value	39

Population analysed: Intention-to-treat (ITT) definition: ITT subjects include all subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and whose target lesion was successfully crossed and predilated.

Primary outcome: Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set)

Time frame: 1 year. Count of participants. Unit: Participants

Measure	CTO Treatment n = 183
Value	15

Population analysed: Per-protocol (PP) definition: The per-protocol population is defined as all ITT subjects in whom at least 1 study stent was implanted, met procedure success, had available follow up data (i.e. a MACE event within 360 days or follow up of at least 330 days), and did not have major protocol deviations due to inappropriate enrollment.

Primary outcome: Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI)

Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes. Number (95% Confidence Interval). Unit: percentage of participants

Measure	CTO Treatment n = 138
Guide Wire-related Endpoint	79.0 (71.2 to 85.5)
Component 1	89.9 (83.6 to 94.3)
Component 2	89.1 (82.7 to 93.8)

Population analysed: All the subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and in whom an attempt was made to cross the target lesion with the HT Progress or the HT Pilot guide wires, are included in the ITT population for the guide wire-related analysis.

Primary outcome: Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI)

Time frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes. Number (95% Confidence Interval). Unit: percentage of participants

Measure	CTO Treatment n = 138
Guide Wire-related Endpoint	87.7 (81 to 92.7)
Component 1	89.9 (83.6 to 94.3)
Component 2	97.8 (93.8 to 99.5)

90 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CTO Treatment	92 of 222 (41.4%)	141 of 222 (63.5%)	20 of 222

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25912400Kandzari DE, Kini AS, Karmpaliotis D, Moses JW, Tummala PE, Grantham JA, Orr C, Lombardi W, Nicholson WJ, Lembo NJ, Popma JJ, Wang J, Larracas C, Rutledge DR. Safety and Effectiveness of Everolimus-Eluting Stents in Chronic Total Coronary Occlusion Revascularization: Results From the EXPERT CTO Multicenter Trial (Evaluation of the XIENCE Coronary Stent, Performance, and Technique in Chronic Total Occlusions). JACC Cardiovasc Interv. 2015 May;8(6):761-769. doi: 10.1016/j.jcin.2014.12.238. Epub 2015 Apr 22.

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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.

David E. Kandzari, MD principal investigator

Piedmont Heart Institute

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

Questions about this trial

What is this clinical trial studying?

A study testing CTO Treatment Device in people with Coronary Artery Disease (CAD) and Chronic Total Occlusion (CTO), run by Abbott Medical Devices at 1 site in United States.

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 0 inclusion and 10 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 9 May 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 United States. 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 25 Nov 2014). 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 Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set) (time frame: 1 year). The study lists 5 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 NCT01435031, 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 9 May 2018.