Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01435031
First received: September 13, 2011
Last updated: November 14, 2014
Last verified: November 2014
  Purpose

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 Dilatation Catheter in patients undergoing elective percutaneous revascularization of native chronic total coronary occlusions


Condition Intervention
Coronary Artery Disease (CAD)
Chronic Total Occlusion (CTO)
Device: CTO Treatment Device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.

  • Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.

  • Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI) [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]

    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)

  • Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (MACE Includes Per Protocol Definition of MI) [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]

    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)

  • Angioplasty Predilatation-related: Successful Predilatation of the CTO [ Time Frame: At time of procedure ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Minimum Lumen Diameter (MLD): Pre-procedure [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: No ]

    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.


  • Minimum Lumen Diameter (MLD): Post-procedure [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: No ]

    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.


  • Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: No ]

    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.


  • Change in TIMI Flow Grade: Post-procedure [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: No ]

    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.


  • Device Success [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: No ]
    Achievement of <50% diameter stenosis within the target lesion segment using assigned study device

  • Procedure Success [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    Device success and absence of in-hospital MACE

  • Procedural Success With Antegrade Crossing [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    per protocol

  • Procedural Success With STAR Technique [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    per protocol; antegrade crossing method

  • Procedural Success With Knuckle Wire [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    per protocol; antegrade crossing method

  • Procedural Success With Primary Retrograde Wire Crossing [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    per protocol

  • Procedural Success With Controlled Antegrade-Retrograde Technique (CART) [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    per protocol

  • Procedural Success With Reverse CART [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    per protocol

  • Procedural Success With Kissing Wire Technique [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    per protocol; combined antegrade and retrograde crossing method

  • Procedural Success With Sub Intimal Technique [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    per protocol

  • Procedural Success With Multiple Crossing Techniques [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    per protocol

  • Resource Utilization: Procedural Time [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: No ]
  • Resource Utilization: Fluoroscopic Time [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: No ]
  • Resource Utilization: Contrast Volume [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: No ]
  • Clinically Significant Perforation [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    Any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft or comparable therapy

  • Major Adverse Cardiac Events (MACE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

  • Major Adverse Cardiac Events (MACE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

  • Major Adverse Cardiac Events (MACE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

  • Major Adverse Cardiac Events (MACE) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

  • Major Adverse Cardiac Events (MACE) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

  • Major Adverse Cardiac Events (MACE) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

  • Major Adverse Cardiac Events (MACE) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

  • Death [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    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).


  • Death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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).


  • Death [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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).


  • Death [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    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).


  • Death [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    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).


  • Death [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

    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).


  • Death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    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).


  • Cardiac Death [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    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

  • Cardiac Death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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

  • Cardiac Death [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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

  • Cardiac Death [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    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

  • Cardiac Death [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    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

  • Cardiac Death [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

    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

  • Cardiac Death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    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

  • Myocardial Infarction Q Wave and Non-Q Wave (MI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    MACE Component; per protocol

    Myocardial Infarction (Protocol Definition)

    • Q wave MI: development of new, pathological Q wave on the ECG
    • Non-Q-wave MI: elevation of CK levels to ≥ 2 x upper limit of normal (ULN) with elevated Creatine kinase myocardial-band isoenzyme (CK-MB) in the absence of new pathological Q waves

  • Myocardial Infarction Q Wave and Non-Q Wave (MI) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    MACE Component; per protocol. Myocardial Infarction (Protocol Definition)

    • Q wave MI: development of new, pathological Q wave on the ECG
    • Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves

  • Myocardial Infarction Q Wave and Non-Q Wave (MI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    MACE Component; per protocol. Myocardial Infarction (Protocol Definition)

    • Q wave MI: development of new, pathological Q wave on the ECG
    • Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves

  • Myocardial Infarction Q Wave and Non-Q Wave (MI) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    MACE Component; per protocol. Myocardial Infarction (Protocol Definition)

    • Q wave MI: development of new, pathological Q wave on the ECG
    • Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves

  • Myocardial Infarction Q Wave and Non-Q Wave (MI) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    MACE Component; per protocol. Myocardial Infarction (Protocol Definition)

    • Q wave MI: development of new, pathological Q wave on the ECG
    • Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves

  • Myocardial Infarction Q Wave and Non-Q Wave (MI) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

    MACE Component; per protocol. Myocardial Infarction (Protocol Definition)

    • Q wave MI: development of new, pathological Q wave on the ECG
    • Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves

  • Myocardial Infarction Q Wave and Non-Q Wave (MI) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    MACE Component; per protocol. Myocardial Infarction (Protocol Definition)

    • Q wave MI: development of new, pathological Q wave on the ECG
    • Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves

  • Target Vessel-related MI [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    TLF Component; per protocol

    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.


  • Target Vessel-related MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    TLF Component; per protocol

    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.


  • Target Vessel-related MI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    TLF Component; per protocol

    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.


  • Target Vessel-related MI [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    TLF Component; per protocol

    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.


  • Target Vessel-related MI [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    TLF Component; per protocol

    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.


  • Target Vessel-related MI [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

    TLF Component; per protocol

    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.


  • Target Vessel-related MI [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    TLF Component; per protocol

    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.


  • Target Lesion Revascularization (TLR) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Repeat percutaneous coronary intervention (PCI) or Coronary artery bypass graft (CABG) to the target lesion/site.

  • Target Lesion Revascularization (TLR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Repeat PCI or CABG to the target lesion/site.

  • Target Lesion Revascularization (TLR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Repeat PCI or CABG to the target lesion/site.

  • Target Lesion Revascularization (TLR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Repeat PCI or CABG to the target lesion/site.

  • Target Lesion Revascularization (TLR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Repeat PCI or CABG to the target lesion/site.

  • Target Lesion Revascularization (TLR) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Repeat PCI or CABG to the target lesion/site.

  • Target Lesion Revascularization (TLR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Repeat PCI or CABG to the target lesion/site.

  • Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.

  • Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.

  • Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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.

  • Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.

  • Target Vessel Revascularization (TVR) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Repeat PCI or CABG of the target vessel.

  • Target Vessel Revascularization (TVR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Repeat PCI or CABG of the target vessel.

  • Target Vessel Revascularization (TVR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Repeat PCI or CABG of the target vessel.

  • Target Vessel Revascularization (TVR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Repeat PCI or CABG of the target vessel.

  • Target Vessel Revascularization (TVR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Repeat PCI or CABG of the target vessel.

  • Target Vessel Revascularization (TVR) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Repeat PCI or CABG of the target vessel.

  • Target Vessel Revascularization (TVR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Repeat PCI or CABG of the target vessel.

  • Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.

  • Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.

  • Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.

  • Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.

  • Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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.

  • Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    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.

  • Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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.

  • Target Vessel Failure (TVF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    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.

  • Target Vessel Failure (TVF) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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.

  • Target Vessel Failure (TVF) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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.

  • Target Vessel Failure (TVF) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    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.

  • Target Vessel Failure (TVF) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    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.

  • Target Vessel Failure (TVF) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

    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.

  • Target Vessel Failure (TVF) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    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.

  • Target Lesion Failure (TLF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.

  • Target Lesion Failure (TLF) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.

  • Target Lesion Failure (TLF) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.

  • Target Lesion Failure (TLF) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Composite of cardiac death, target vessel-related MI, and clinically-driven TLR

  • Target Lesion Failure (TLF) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Composite of cardiac death, target vessel-related MI, and clinically-driven TLR

  • Target Lesion Failure (TLF) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Composite of cardiac death, target vessel-related MI, and clinically-driven TLR

  • Target Lesion Failure (TLF) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Composite of cardiac death, target vessel-related MI, and clinically-driven TLR

  • Stent Thrombosis [ Time Frame: Acute (0-24 hours) ] [ Designated as safety issue: Yes ]

    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.


  • Stent Thrombosis [ Time Frame: Subacute (>24 hours to 30 days) ] [ Designated as safety issue: Yes ]

    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.


  • Stent Thrombosis [ Time Frame: Late (>30 days to 1 year) ] [ Designated as safety issue: Yes ]

    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.


  • Stent Thrombosis [ Time Frame: very late (>1 year) ] [ Designated as safety issue: Yes ]

    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.


  • Stent Thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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.


  • Stent Thrombosis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    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.


  • Stent Thrombosis [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    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.


  • Stent Thrombosis [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

    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.


  • Stent Thrombosis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    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.


  • Occurrence of Stent Fracture at Target Lesion [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.

  • Occurrence of Stent Fracture at Target Lesion [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.

  • Occurrence of Stent Fracture at Target Lesion [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.

  • Occurrence of Stent Fracture at Target Lesion [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.

  • Occurrence of Stent Fracture at Target Lesion [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.


Enrollment: 250
Study Start Date: September 2011
Estimated Study Completion Date: February 2018
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CTO Treatment

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
Device: CTO Treatment Device

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  1. Subject is ≥ 18 years of age at the time of consent.
  2. Subject is experiencing clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure, etc.) or has evidence of myocardial ischemia (e.g., abnormal functional study) attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization.
  3. Subject is eligible and consents to undergo PCI procedure.
  4. Subject is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergency coronary artery bypass grafting (CABG).
  5. Subject is willing and able to sign an ICF approved by a local Institutional Review Board/Ethics Committee and to follow the protocol with up to 5-year follow up.
  6. Female subjects of child-bearing potential must have a negative qualitative or quantitative pregnancy test within 7 days before enrollment and effective birth control must be used up to 1 year following the index procedure.

Angiographic Inclusion Criteria

  1. A maximum of one de novo lesion with at least one target segment in a native coronary vessel meeting definition of chronic total occlusion. A "chronic total occlusion" is any non-acute total coronary occlusion fulfilling the following angiographic characteristics and estimated in duration at least 3 months by clinical history and/or comparison with antecedent angiogram or electrocardiogram:

    • High-grade native coronary stenosis
    • TIMI 0 or 1 antegrade flow
  2. Occluded segment suitable for placement of coronary stents:

    • Segment without severe tortuosity (angulation ≥ 45º)
    • Segment not located in an excessively distal location

General Exclusion Criteria

Candidates will be excluded from the study if any of the following conditions are present:

  1. Patients with any history of allergy to iodinated contrast that cannot be effectively managed medically, or any known allergy to clopidogrel bisulfate (Plavix®), aspirin, heparin, stainless steel, or everolimus
  2. Evidence of acute MI within 72 hours of the intended treatment (defined as: Q-wave or non-Q-wave MI having creatine kinase (CK) enzymes 2 × the upper limit of normal (ULN) with the presence of a creatine kinase myocardial-band isoenzyme (CK-MB) above the Institution's ULN, or troponin (I or T) above the Institution's ULN)
  3. Previous coronary interventional procedure of any kind within the 30 days prior to the procedure in the target vessel
  4. Planned interventional treatment of either the target or any non-target vessel within 30 days post-procedure
  5. Planned interventional treatment of either the target or any non-target vessel within 6 months post-procedure with any alternative DES (e.g., CYPHER Sirolimus-Eluting stent, TAXUS Paclitaxel-Eluting stent or Endeavor Zotarolimus-Eluting Endeavor stent)
  6. Any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and PCI (e.g., aspirin, clopidogrel, unfractionated heparin)
  7. Target lesion requires treatment with a device after successful crossing other than PTCA prior to stent placement (including, but not limited to directional or rotational coronary atherectomy, excimer laser, thrombectomy, etc.). Note: Use of alternative technologies to conventional guide wires that are approved by the United States Food and Drug Administration for CTO revascularization (e.g., Asahi Tornus and Corsair catheters, IntraLuminal Therapeutics SafeCross guide wire, Flowcardia CROSSER system) is permitted and will be collected in the case report form.
  8. Patients with history of clinically significant abnormal laboratory findings including:

    • Neutropenia (<1000 neutrophils/mm3) within the previous 2 weeks, or
    • Thrombocytopenia (<100,000 platelets/mm3), or
    • AST, ALT, alkaline phosphatase, or bilirubin > 1.5 × ULN, or
    • Serum creatinine > 1.5 mg/dL
  9. Patients with evidence of ongoing or active clinical instability including the following:

    • Sustained systolic blood pressure < 100 mmHg or cardiogenic shock
    • Acute pulmonary edema or severe congestive heart failure
    • Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade
    • Suspected dissecting aortic aneurysm
    • Hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease
  10. Target lesion involves a bifurcation including a diseased side branch ≥2.25 mm in diameter that would require treatment
  11. Target vessel with a patent bypass graft from prior coronary bypass surgery
  12. Proximal coronary stenting of target lesion
  13. History of stroke or transient ischemic attack within the prior 6 months
  14. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
  15. History of bleeding diathesis or coagulopathy or refusal of blood transfusions
  16. Patients with any other pathology such as cancer, mental illness, etc., which in the opinion of the Investigator, might put the patient at risk, preclude follow-up, or in any way confound the results of the study.
  17. Known previous medical condition yielding expected survival less than 1 year.
  18. Patients who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements.
  19. Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound (IVUS), or other coronary artery imaging procedures

Angiographic Exclusion Criteria

Candidates will be excluded from study if any of the following conditions are met:

  1. Occlusion involves segment within previous stent
  2. Extensive lesion-related thrombus (TIMI thrombus grade 3 or 4)
  3. Previous stenting (drug-eluting or bare metal) in the target vessel unless the following conditions are met:

    • It has been at least 9 months since the previous stenting.
    • That target lesion is at least 15 mm away from the previously placed stent.
    • The previously stented segment (stent plus 5 mm on either side) has no more than 40% diameter stenosis.
  4. The target vessel has other lesions proximal to the total occlusion identified with greater than 40% diameter stenosis based on visual estimate or on-line quantitative coronary angiography (QCA). However, planned stenting of the lesion in target vessel which is proximal to the target lesion and can be covered by a single stent (ie, tandem lesions) are acceptable.

Exclusion Criteria (Non-target Lesion):

  1. The lesion is located in a native vessel distal to anastomosis with a graft.
  2. The vessel has other lesions with greater than 40% diameter stenosis based on visual estimate or on-line QCA.
  3. The vessel has evidence of thrombus.
  4. The vessel is excessively tortuous.
  5. 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).
    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435031

Locations
United States, California
Abbott Vascular
Santa Clara, California, United States, 95054
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: David E. Kandzari, MD Piedmont Heart Institute
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01435031     History of Changes
Other Study ID Numbers: 11-394
Study First Received: September 13, 2011
Results First Received: November 14, 2014
Last Updated: November 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
Angioplasty
Chronic Total Occlusion (CTO)
Chronic total coronary occlusions
Coronary Artery Disease (CAD)
Coronary artery stenosis
Total coronary occlusion

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014