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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: October 23, 2014
Last verified: October 2014

September 16, 2010
October 23, 2014
September 2010
April 2016   (final data collection date for primary outcome measure)
Composite measure of all-cause mortality, myocardial infarction (MI) or stroke. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Composite measure of all-cause mortality, myocardial infarction or stroke. [ Time Frame: At an anticipated median follow-up duration of three years (with all randomized subjects having reached a minimum of two years follow-up). ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01205776 on ClinicalTrials.gov Archive Site
  • Composite of all-cause mortality, myocardial infarction (MI) and stroke. [ Time Frame: 30 days ] [ 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)
  • Composite measure of all-cause mortality, myocardial infarction, stroke or unplanned revascularization for ischemia. [ Time Frame: At an anticipated median follow-up duration of three years (with all randomized subjects having reached a minimum of two years follow-up). ] [ Designated as safety issue: Yes ]
    Major Secondary Endpoint
  • All cause mortality [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]
    in-hospital is from time of admission to time of discharge from the hospital.
  • All cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 3 yrs ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 4 yrs ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 5 yrs ] [ 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: 180 days ] [ Designated as safety issue: Yes ]
  • All myocardial infarctions [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
  • All myocardial infarctions [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]
  • All myocardial infarctions [ Time Frame: 3 yrs ] [ Designated as safety issue: Yes ]
  • All myocardial infarctions [ Time Frame: 4 yrs ] [ Designated as safety issue: Yes ]
  • All myocardial infarctions [ Time Frame: 5 yrs ] [ 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 ]
  • Stroke [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 3 yrs ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 4 yrs ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 5 yrs ] [ Designated as safety issue: Yes ]
  • 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: 180 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: 1 yr ] [ 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 yrs ] [ 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 yrs ] [ 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 yrs ] [ 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 yrs ] [ Designated as safety issue: No ]
    • All target lesion revascularization (TLR)
    • All target vessel revascularization (TVR)
    • All non target vessel revascularization (non TVR)
  • Complete revascularization at baseline procedure, anatomic and functional [ Time Frame: in-hospital ] [ Designated as safety issue: No ]
  • Complete revascularization at baseline procedure, anatomic and functional [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Complete revascularization at baseline procedure, anatomic and functional [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Complete revascularization at baseline procedure, anatomic and functional [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
  • Complete revascularization at baseline procedure, anatomic and functional [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
  • Complete revascularization at baseline procedure, anatomic and functional [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
  • Complete revascularization at baseline procedure, anatomic and functional [ Time Frame: 4 yrs ] [ Designated as safety issue: No ]
  • Complete revascularization at baseline procedure, anatomic and functional [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
  • 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: 180 days ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (ARC definition) [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (ARC definition) [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (ARC definition) [ Time Frame: 3 yrs ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (ARC definition) [ Time Frame: 4 yrs ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (ARC definition) [ Time Frame: 5 yrs ] [ 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: 180 Days ] [ Designated as safety issue: Yes ]
  • Symptomatic graft stenosis or occlusion [ Time Frame: 1 Yr ] [ Designated as safety issue: Yes ]
  • Symptomatic graft stenosis or occlusion [ Time Frame: 2 Yrs ] [ Designated as safety issue: Yes ]
  • Symptomatic graft stenosis or occlusion [ Time Frame: 3 Yrs ] [ Designated as safety issue: Yes ]
  • Symptomatic graft stenosis or occlusion [ Time Frame: 4 Yrs ] [ Designated as safety issue: Yes ]
  • Symptomatic graft stenosis or occlusion [ Time Frame: 5 Yrs ] [ Designated as safety issue: Yes ]
  • Bleeding complications [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]
  • Bleeding complications [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • Bleeding complications [ Time Frame: 180 Days ] [ Designated as safety issue: Yes ]
  • Bleeding complications [ Time Frame: 1 Yr ] [ Designated as safety issue: Yes ]
  • Bleeding complications [ Time Frame: 2 Yrs ] [ Designated as safety issue: Yes ]
  • Bleeding complications [ Time Frame: 3 Yrs ] [ Designated as safety issue: Yes ]
  • Bleeding complications [ Time Frame: 4 Yrs ] [ Designated as safety issue: Yes ]
  • Bleeding complications [ Time Frame: 5 Yrs ] [ Designated as safety issue: Yes ]
  • Major adverse events (MAE) [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]
    • death
    • myocardial infarction
    • stroke
    • TIMI major or minor bleeding
    • transfusion
    • 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
    • TIMI major or minor bleeding
    • transfusion
    • 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.
  • Quality of Life and Health Economics [ Time Frame: in-house ] [ Designated as safety issue: No ]
    Quality of Life Questionnaires administered to patients and Health Economics data collected.
  • Quality of Life and Health Economics [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Quality of Life Questionnaires administered to patients and Health Economics data collected.
  • Quality of Life and Health Economics [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    Quality of Life Questionnaires administered to patients and Health Economics data collected.
  • Quality of Life and Health Economics [ Time Frame: 1 Yr ] [ Designated as safety issue: No ]
    Quality of Life Questionnaires administered to patients and Health Economics data collected.
  • Quality of Life and Health Economics [ Time Frame: 2 Yrs ] [ Designated as safety issue: No ]
    Quality of Life Questionnaires administered to patients and Health Economics data collected.
  • Quality of Life and Health Economics [ Time Frame: 3 Yrs ] [ Designated as safety issue: No ]
    Quality of Life Questionnaires administered to patients and Health Economics data collected.
  • Quality of Life and Health Economics [ Time Frame: 4 Yrs ] [ Designated as safety issue: No ]
    Quality of Life Questionnaires administered to patients and Health Economics data collected.
  • Quality of Life and Health Economics [ Time Frame: 5 Yrs ] [ Designated as safety issue: No ]
    Quality of Life Questionnaires administered to patients and Health Economics data collected.
  • 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 ]
Not Provided
Not Provided
 
EXCEL Clinical Trial
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

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].
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
    Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
  • Procedure: CABG
    Those patients receiving CABG
  • Active Comparator: Percutaneous Coronary Intervention
    Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
    Intervention: Device: Percutaneous Coronary Intervention
  • Active Comparator: Coronary Artery Bypass Graft
    Those patients receiving CABG
    Intervention: Procedure: CABG
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1905
December 2019
April 2016   (final data collection date for primary outcome measure)

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, or
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01205776
10-389
Yes
Abbott Vascular
Abbott Vascular
Not Provided
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
Abbott Vascular
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP