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EXCEL Clinical Trial (EXCEL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01205776
First received: September 16, 2010
Last updated: January 31, 2017
Last verified: January 2017
  Purpose
To establish the safety and efficacy of the commercially approved XIENCE Family Stent System (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO [for use outside the United States [OUS] only]) in subjects with unprotected left main coronary artery disease by comparing to coronary artery bypass graft surgery.

Condition Intervention
Chronic Coronary Occlusion
Unprotected Left Main Coronary Artery Disease
Stent Thrombosis
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Device: Percutaneous Coronary Intervention
Procedure: CABG

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization.

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Composite measure of all-cause mortality, myocardial infarction (MI) or stroke. [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Composite of all-cause mortality, myocardial infarction (MI) or stroke. [ Time Frame: 3 years ]
  • Composite of all-cause mortality, MI, stroke, or unplanned revascularization for ischemia [ Time Frame: 3 years ]
  • All myocardial infarctions (peri-procedural, spontaneous, Q-wave and non Q-wave) [ Time Frame: in-hospital ]
  • All myocardial infarctions (peri-procedural, spontaneous, Q-wave and non Q-wave) [ Time Frame: 30 days ]
  • All myocardial infarctions (peri-procedural, spontaneous, Q-wave and non Q-wave) [ Time Frame: 6 months ]
  • All myocardial infarctions (peri-procedural, spontaneous, Q-wave and non Q-wave) [ Time Frame: 1 year ]
  • All myocardial infarctions (peri-procedural, spontaneous, Q-wave and non Q-wave) [ Time Frame: 2 years ]
  • All myocardial infarctions (peri-procedural, spontaneous, Q-wave and non Q-wave) [ Time Frame: 3 years ]
  • All myocardial infarctions (peri-procedural, spontaneous, Q-wave and non Q-wave) [ Time Frame: 4 years ]
  • All myocardial infarctions (peri-procedural, spontaneous, Q-wave and non Q-wave) [ Time Frame: 5 years ]
  • Stroke (all, ischemic and hemorrhagic) [ Time Frame: in-hospital ]
    Defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause.

  • Stroke (all, ischemic and hemorrhagic) [ Time Frame: 30 days ]
    Defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause.

  • Stroke (all, ischemic and hemorrhagic) [ Time Frame: 6 months ]
    Defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause.

  • Stroke (all, ischemic and hemorrhagic) [ Time Frame: 1 year ]
    Defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause.

  • Stroke (all, ischemic and hemorrhagic) [ Time Frame: 2 years ]
    Defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause.

  • Stroke (all, ischemic and hemorrhagic) [ Time Frame: 3 years ]
    Defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause.

  • Stroke (all, ischemic and hemorrhagic) [ Time Frame: 4 years ]
    Defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause.

  • Stroke (all, ischemic and hemorrhagic) [ Time Frame: 5 years ]
    Defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause.

  • All revascularization [ Time Frame: in-hospital ]
    • All target lesion revascularization (TLR)
    • All target vessel revascularization (TVR)
    • All non target vessel revascularization (non TVR)

  • All revascularization [ Time Frame: 30 days ]
    • All target lesion revascularization (TLR)
    • All target vessel revascularization (TVR)
    • All non target vessel revascularization (non TVR)

  • All revascularization [ Time Frame: 6 months ]
    • All target lesion revascularization (TLR)
    • All target vessel revascularization (TVR)
    • All non target vessel revascularization (non TVR)

  • All revascularization [ Time Frame: 1 year ]
    • All target lesion revascularization (TLR)
    • All target vessel revascularization (TVR)
    • All non target vessel revascularization (non TVR)

  • All revascularization [ Time Frame: 2 years ]
    • All target lesion revascularization (TLR)
    • All target vessel revascularization (TVR)
    • All non target vessel revascularization (non TVR)

  • All revascularization [ Time Frame: 3 years ]
    • All target lesion revascularization (TLR)
    • All target vessel revascularization (TVR)
    • All non target vessel revascularization (non TVR)

  • All revascularization [ Time Frame: 4 years ]
    • All target lesion revascularization (TLR)
    • All target vessel revascularization (TVR)
    • All non target vessel revascularization (non TVR)

  • All revascularization [ Time Frame: 5 years ]
    • All target lesion revascularization (TLR)
    • All target vessel revascularization (TVR)
    • All non target vessel revascularization (non TVR)

  • Complete revascularization [ Time Frame: at baseline procedure in-hospital ]
    Measurement of anatomic and functional change post-procedure.

  • Stent thrombosis (ARC definition) [ Time Frame: in-hospital ]
  • Stent thrombosis (ARC definition) [ Time Frame: 30 days ]
  • Stent thrombosis (ARC definition) [ Time Frame: 6 months ]
  • Stent thrombosis (ARC definition) [ Time Frame: 1 year ]
  • Stent thrombosis (ARC definition) [ Time Frame: 2 years ]
  • Stent thrombosis (ARC definition) [ Time Frame: 3 years ]
  • Stent thrombosis (ARC definition) [ Time Frame: 4 years ]
  • Stent thrombosis (ARC definition) [ Time Frame: 5 years ]
  • Symptomatic graft stenosis or occlusion [ Time Frame: in-hospital ]
  • Symptomatic graft stenosis or occlusion [ Time Frame: 30 days ]
  • Symptomatic graft stenosis or occlusion [ Time Frame: 6 months ]
  • Symptomatic graft stenosis or occlusion [ Time Frame: 1 year ]
  • Symptomatic graft stenosis or occlusion [ Time Frame: 2 years ]
  • Symptomatic graft stenosis or occlusion [ Time Frame: 3 years ]
  • Symptomatic graft stenosis or occlusion [ Time Frame: 4 years ]
  • Symptomatic graft stenosis or occlusion [ Time Frame: 5 years ]
  • Bleeding complications [ Time Frame: in-hospital ]
    • Requirement for blood product transfusion
    • TIMI (Thrombolysis In Myocardial Infarction) scale
    • BARC (Bleeding Academic Research Consortium) scale

  • Bleeding complications [ Time Frame: 30 days ]
    • Requirement for blood product transfusion
    • TIMI scale (major or minor)
    • BARC scale

  • Bleeding complications [ Time Frame: 6 months ]
    • Requirement for blood product transfusion
    • TIMI scale (major or minor)
    • BARC scale

  • Bleeding complications [ Time Frame: 1 year ]
    • Requirement for blood product transfusion
    • TIMI scale (major or minor)
    • BARC scale

  • Bleeding complications [ Time Frame: 2 years ]
    • Requirement for blood product transfusion
    • TIMI scale (major or minor)
    • BARC scale

  • Bleeding complications [ Time Frame: 3 years ]
    • Requirement for blood product transfusion
    • TIMI scale (major or minor)
    • BARC scale

  • Bleeding complications [ Time Frame: 4 years ]
    • Requirement for blood product transfusion
    • TIMI scale (major or minor)
    • BARC scale

  • Bleeding complications [ Time Frame: 5 years ]
    • Requirement for blood product transfusion
    • TIMI scale (major or minor)
    • BARC scale

  • Major adverse events (MAE) [ Time Frame: in-hospital ]
    • death
    • myocardial infarction
    • stroke
    • Transfusion of ≥2 units of blood
    • TIMI major or minor bleeding
    • major arrhythmia
    • unplanned coronary revascularization for ischemia
    • any unplanned surgery or therapeutic radiologic procedure
    • renal failure
    • sternal wound dehiscence
    • infection requiring antibiotics for treatment
    • intubation for > 48 hours
    • post-pericardiotomy syndrome

  • Major adverse events (MAE) [ Time Frame: 30 days ]
    • death
    • myocardial infarction
    • stroke
    • Transfusion of ≥2 units of blood
    • TIMI major or minor bleeding
    • major arrhythmia
    • unplanned coronary revascularization for ischemia
    • any unplanned surgery or therapeutic radiologic procedure
    • renal failure
    • sternal wound dehiscence
    • infection requiring antibiotics for treatment
    • intubation for > 48 hours
    • post-pericardiotomy syndrome

  • Time from randomization to procedure [ Time Frame: Time from randomization to procedure ]
  • Time from procedure to discharge [ Time Frame: Time from procedure to discharge ]
  • ICU days [ Time Frame: in-hospital ]
  • Time from procedure to return to work [ Time Frame: Time from procedure to return to work ]
  • MI adjudicated per Universal MI Definition [ Time Frame: In-hospital ]
  • MI adjudicated per Universal MI Definition [ Time Frame: 30 days ]
  • MI adjudicated per Universal MI Definition [ Time Frame: 6 months ]
  • MI adjudicated per Universal MI Definition [ Time Frame: 1 year ]
  • MI adjudicated per Universal MI Definition [ Time Frame: 2 years ]
  • MI adjudicated per Universal MI Definition [ Time Frame: 3 years ]
  • MI adjudicated per Universal MI Definition [ Time Frame: 4 years ]
  • MI adjudicated per Universal MI Definition [ Time Frame: 5 years ]
  • Protocol-defined MI [ Time Frame: in-hospital ]
    Protocol-defined is an identical definition for MI after both PCI and CABG to eliminate ascertainment bias. Only prognostically important MI that has clearly been associated with subsequent mortality will be included in the primary endpoint.

  • Protocol-defined MI [ Time Frame: 30 days ]
    Protocol-defined is an identical definition for MI after both PCI and CABG to eliminate ascertainment bias. Only prognostically important MI that has clearly been associated with subsequent mortality will be included in the primary endpoint.

  • Protocol-defined MI [ Time Frame: 6 months ]
    Protocol-defined is an identical definition for MI after both PCI and CABG to eliminate ascertainment bias. Only prognostically important MI that has clearly been associated with subsequent mortality will be included in the primary endpoint.

  • Protocol-defined MI [ Time Frame: 1 year ]
    Protocol-defined is an identical definition for MI after both PCI and CABG to eliminate ascertainment bias. Only prognostically important MI that has clearly been associated with subsequent mortality will be included in the primary endpoint.

  • Protocol-defined MI [ Time Frame: 2 years ]
    Protocol-defined is an identical definition for MI after both PCI and CABG to eliminate ascertainment bias. Only prognostically important MI that has clearly been associated with subsequent mortality will be included in the primary endpoint.

  • Protocol-defined MI [ Time Frame: 3 years ]
    Protocol-defined is an identical definition for MI after both PCI and CABG to eliminate ascertainment bias. Only prognostically important MI that has clearly been associated with subsequent mortality will be included in the primary endpoint.

  • Protocol-defined MI [ Time Frame: 4 years ]
    Protocol-defined is an identical definition for MI after both PCI and CABG to eliminate ascertainment bias. Only prognostically important MI that has clearly been associated with subsequent mortality will be included in the primary endpoint.

  • Protocol-defined MI [ Time Frame: 5 years ]
    Protocol-defined is an identical definition for MI after both PCI and CABG to eliminate ascertainment bias. Only prognostically important MI that has clearly been associated with subsequent mortality will be included in the primary endpoint.

  • Disability following stroke event [ Time Frame: 90 days ]
  • All cause mortality (cardiac death and non-cardiac death) [ Time Frame: in-hospital ]
  • All cause mortality (cardiac death and non-cardiac death) [ Time Frame: 30 days ]
  • All cause mortality (cardiac death and non-cardiac death) [ Time Frame: 6 months ]
  • All cause mortality (cardiac death and non-cardiac death) [ Time Frame: 1 year ]
  • All cause mortality (cardiac death and non-cardiac death) [ Time Frame: 2 years ]
  • All cause mortality (cardiac death and non-cardiac death) [ Time Frame: 3 years ]
  • All cause mortality (cardiac death and non-cardiac death) [ Time Frame: 4 years ]
  • All cause mortality (cardiac death and non-cardiac death) [ Time Frame: 5 years ]
  • Requirement for blood product transfusion [ Time Frame: in-hospital ]
  • Requirement for blood product transfusion [ Time Frame: 30 days ]
  • Requirement for blood product transfusion [ Time Frame: 6 months ]
  • Requirement for blood product transfusion [ Time Frame: 1 year ]
  • Requirement for blood product transfusion [ Time Frame: 2 years ]
  • Requirement for blood product transfusion [ Time Frame: 4 years ]
  • Requirement for blood product transfusion [ Time Frame: 5 years ]
  • Ischemia-driven revascularization [ Time Frame: in hospital ]
    • Ischemia-driven target lesion revascularization (TLR)
    • Ischemia-driven target vessel revascularization (TVR)
    • Ischemia-driven non target vessel revascularization (Non-TVR)

  • Ischemia-driven revascularization [ Time Frame: 30 days ]
    • Ischemia-driven target lesion revascularization (TLR)
    • Ischemia-driven target vessel revascularization (TVR)
    • Ischemia-driven non target vessel revascularization (Non-TVR)

  • Ischemia-driven revascularization [ Time Frame: 6 months ]
    • Ischemia-driven target lesion revascularization (TLR)
    • Ischemia-driven target vessel revascularization (TVR)
    • Ischemia-driven non target vessel revascularization (Non-TVR)

  • Ischemia-driven revascularization [ Time Frame: 1 year ]
    • Ischemia-driven target lesion revascularization (TLR)
    • Ischemia-driven target vessel revascularization (TVR)
    • Ischemia-driven non target vessel revascularization (Non-TVR)

  • Ischemia-driven revascularization [ Time Frame: 2 years ]
    • Ischemia-driven target lesion revascularization (TLR)
    • Ischemia-driven target vessel revascularization (TVR)
    • Ischemia-driven non target vessel revascularization (Non-TVR)

  • Ischemia-driven revascularization [ Time Frame: 3 years ]
    • Ischemia-driven target lesion revascularization (TLR)
    • Ischemia-driven target vessel revascularization (TVR)
    • Ischemia-driven non target vessel revascularization (Non-TVR)

  • Ischemia-driven revascularization [ Time Frame: 4 years ]
    • Ischemia-driven target lesion revascularization (TLR)
    • Ischemia-driven target vessel revascularization (TVR)
    • Ischemia-driven non target vessel revascularization (Non-TVR)

  • Ischemia-driven revascularization [ Time Frame: 5 years ]
    • Ischemia-driven target lesion revascularization (TLR)
    • Ischemia-driven target vessel revascularization (TVR)
    • Ischemia-driven non target vessel revascularization (Non-TVR)


Enrollment: 1905
Study Start Date: September 2010
Estimated Study Completion Date: December 2019
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Percutaneous Coronary Intervention
Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
Device: Percutaneous Coronary Intervention
Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
Active Comparator: Coronary Artery Bypass Graft
Those patients receiving CABG
Procedure: CABG
Those patients receiving CABG

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

* Inclusion criteria for RCT:

  • Unprotected left main coronary artery (ULMCA) disease with angiographic diameter stenosis (DS) ≥70% requiring revascularization, or
  • ULMCA disease with agniographic DS >=50% but < 70% requiring revascularization, with one or more of the following present:

    • Non-invasive evidence of ischemia referable to a hemodynamically significant left main lesion (large area of ischemia in both the LAD and LCX territories, or in either the LAD or LCX territory in the absence of other obstructive coronary artery disease to explain the LAD or LCX defect), or stress-induced hypotension or stress-induced fall in LVEF, or stress-induced transient ischemic dilatation of the left ventricle or stress-induced thallium/technetiumlung uptake, and/or
    • IVUS minimum lumen area (MLA) <= 6.0mm2, and/or
    • Fractional Flow Reserve (FFR) <=0.80
  • Left Main Equivalent Disease
  • Clinical and anatomic eligibility for both PCI and CABG
  • Silent ischemia, stable angina, unstable angina or recent MI
  • Ability to sign informed consent and comply with all study procedures including follow-up for at least three years

Exclusion Criteria:

* Clinical exclusion criteria:

  • Prior PCI of the left main trunk at any time prior to randomization
  • Prior PCI of any other coronary artery lesions within one year prior to randomization
  • Prior CABG at any time prior to randomization
  • Need for any concomitant cardiac surgery other than CABG, or intent that if the subject randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed
  • CK-MB greater than the local laboratory upper limit of normal or recent MI with CK-MB still elevated
  • Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year
  • Subjects requiring or who may require additional surgery within one year
  • The presence of any clinical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present
  • The presence of any clinical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present
  • Pregnancy or intention to become pregnant
  • Non cardiac co-morbidities with life expectancy less than 3 years
  • Other investigational drug or device studies that have not reached their primary endpoint
  • Vulnerable population who in the judgment of the investigator is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention

Angiographic exclusion criteria:

  • Left main diameter stenosis <50%
  • SYNTAX score ≥33
  • Left main reference vessel diameter <2.25 mm or >4.25 mm
  • The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present
  • The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present
  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: NCT01205776

Locations
United States, California
Abbott Vascular
Santa Clara, California, United States, 95054
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Gregg W Stone, MD Columbia University
Principal Investigator: Patrick W Serruys, MD Erasmus Medical Center
Principal Investigator: Joseph Sabik, MD Cleveland Clinical Main Campus
Principal Investigator: A. Pieter Kappetein, MD Erasmus Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01205776     History of Changes
Other Study ID Numbers: 10-389 
Study First Received: September 16, 2010
Last Updated: January 31, 2017

Keywords provided by Abbott Vascular:
Drug eluting stents
Stents
Unprotected Left Main Coronary Artery Disease
Coronary artery bypass graft surgery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Thrombosis
Ischemia
Vascular Diseases
Coronary Restenosis
Coronary Occlusion
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Embolism and Thrombosis
Pathologic Processes

ClinicalTrials.gov processed this record on February 28, 2017