EXCEL Clinical Trial

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: April 10, 2014
Last verified: April 2014
  Purpose

To establish the safety and efficacy of the XIENCE PRIME or XIENCE V or XIENCE Xpedition or XIENCE PRO Everolimus Eluting Coronary Stent System (EECSS) in subjects with unprotected left main coronary artery disease by comparing to coronary artery bypass graft surgery.

Notes:

  1. XIENCE Xpedition and XIENCE PRO are newly added to the XIENCE Family Stent System.
  2. XIENCE PRO will be used only outside of the United States [OUS].

Condition Intervention Phase
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of XIENCE PRIME™ Everolimus Eluting Stent System (EECSS) or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS 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: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Composite of all-cause mortality, myocardial infarction (MI) and stroke. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Unplanned revascularization for ischemia [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Composite of all-cause mortality, MI, stroke, or unplanned revascularization for ischemia [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • All myocardial infarctions [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]
  • All myocardial infarctions [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • All myocardial infarctions [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • All myocardial infarctions [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • All myocardial infarctions [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • All myocardial infarctions [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • All myocardial infarctions [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • All myocardial infarctions [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    • All target lesion revascularization (TLR)
    • All target vessel revascularization (TVR)
    • All non target vessel revascularization (non TVR)

  • All revascularization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    • All target lesion revascularization (TLR)
    • All target vessel revascularization (TVR)
    • All non target vessel revascularization (non TVR)

  • All revascularization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • All target lesion revascularization (TLR)
    • All target vessel revascularization (TVR)
    • All non target vessel revascularization (non TVR)

  • All revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    • All target lesion revascularization (TLR)
    • All target vessel revascularization (TVR)
    • All non target vessel revascularization (non TVR)

  • All revascularization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    • All target lesion revascularization (TLR)
    • All target vessel revascularization (TVR)
    • All non target vessel revascularization (non TVR)

  • All revascularization [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • All target lesion revascularization (TLR)
    • All target vessel revascularization (TVR)
    • All non target vessel revascularization (non TVR)

  • All revascularization [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    • All target lesion revascularization (TLR)
    • All target vessel revascularization (TVR)
    • All non target vessel revascularization (non TVR)

  • All revascularization [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    Measurement of anatomic and functional change post-procedure.

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

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

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

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

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

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

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

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

  • Major adverse events (MAE) [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]
    • 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 ] [ Designated as safety issue: Yes ]
    • 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 ] [ Designated as safety issue: No ]
  • Time from procedure to discharge [ Time Frame: Time from procedure to discharge ] [ Designated as safety issue: No ]
  • ICU days [ Time Frame: in-hospital ] [ Designated as safety issue: No ]
  • Time from procedure to return to work [ Time Frame: Time from procedure to return to work ] [ Designated as safety issue: No ]
  • MI adjudicated per Universal MI Definition [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]
  • MI adjudicated per Universal MI Definition [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • MI adjudicated per Universal MI Definition [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • MI adjudicated per Universal MI Definition [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • MI adjudicated per Universal MI Definition [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • MI adjudicated per Universal MI Definition [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • MI adjudicated per Universal MI Definition [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • MI adjudicated per Universal MI Definition [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Protocol-defined MI [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Requirement for blood product transfusion [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]
  • Requirement for blood product transfusion [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Requirement for blood product transfusion [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Requirement for blood product transfusion [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Requirement for blood product transfusion [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Requirement for blood product transfusion [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Requirement for blood product transfusion [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Ischemia-driven revascularization [ Time Frame: in hospital ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • Ischemia-driven target lesion revascularization (TLR)
    • Ischemia-driven target vessel revascularization (TVR)
    • Ischemia-driven non target vessel revascularization (Non-TVR)


Estimated Enrollment: 2600
Study Start Date: September 2010
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: April 2017 (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
Genders Eligible for Study:   Both
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 angiographic DS ≥50% but <70% requiring revascularization
  • 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
  • Any recent MI with CK-MB levels 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

No publications provided

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: April 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
Drug eluting stents
Stents
Angioplasty
Unprotected Left Main Coronary Artery Disease

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

ClinicalTrials.gov processed this record on August 18, 2014