N/A
Completed N=1,905
EXCEL Clinical Trial
Chronic Coronary Occlusion · unprotected left main coronary artery disease · Stent Thrombosis · Vascular Disease
Source: ClinicalTrials.gov NCT01205776 ↗
Enrolled (actual)
1,905
Serious AEs
57.0%
Results posted
Mar 2018
Primary outcomePrimary: Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke — 203; 176 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke |
203; 176 | — |
| SECONDARY Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke |
203; 176 | — |
| SECONDARY Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke |
203; 176 | — |
| SECONDARY Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke |
203; 176 | — |
| SECONDARY Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke |
203; 176 | — |
| SECONDARY Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke |
203; 176 | — |
| SECONDARY Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke |
203; 176 | — |
| SECONDARY Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke |
203; 176 | — |
| SECONDARY Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke |
203; 176 | — |
| SECONDARY Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia |
290; 228 | — |
| SECONDARY Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia |
290; 228 | — |
| SECONDARY Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia |
290; 228 | — |
| SECONDARY Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia |
290; 228 | — |
| SECONDARY Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia |
290; 228 | — |
| SECONDARY Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia |
290; 228 | — |
| SECONDARY Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia |
290; 228 | — |
| SECONDARY Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia |
290; 228 | — |
| SECONDARY Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) |
119; 89 | — |
| SECONDARY Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) |
119; 89 | — |
| SECONDARY Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) |
119; 89 | — |
| SECONDARY Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) |
119; 89 | — |
| SECONDARY Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) |
119; 89 | — |
| SECONDARY Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) |
119; 89 | — |
| SECONDARY Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) |
119; 89 | — |
| SECONDARY Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) |
119; 89 | — |
| SECONDARY Number of Participants With Protocol Defined MI |
95; 84 | — |
| SECONDARY Number of Participants With Protocol Defined MI |
95; 84 | — |
| SECONDARY Number of Participants With Protocol Defined MI |
95; 84 | — |
| SECONDARY Number of Participants With Protocol Defined MI |
95; 84 | — |
| SECONDARY Number of Participants With Protocol Defined MI |
95; 84 | — |
| SECONDARY Number of Participants With Protocol Defined MI |
95; 84 | — |
| SECONDARY Number of Participants With Protocol Defined MI |
95; 84 | — |
| SECONDARY Number of Participants With Protocol Defined MI |
95; 84 | — |
| SECONDARY Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) |
26; 33 | — |
| SECONDARY Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) |
26; 33 | — |
| SECONDARY Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) |
26; 33 | — |
| SECONDARY Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) |
26; 33 | — |
| SECONDARY Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) |
26; 33 | — |
| SECONDARY Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) |
26; 33 | — |
| SECONDARY Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) |
26; 33 | — |
| SECONDARY Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) |
26; 33 | — |
| SECONDARY Number of Participants With Disability Following Stroke Event |
6; 9 | — |
| SECONDARY Number of Participants With Ischemia Driven Revascularizations (TLR,TVR and Non-TVR) |
3; 12 | — |
| SECONDARY Number of Participants With Ischemia Driven Revascularizations |
150; 88 | — |
| SECONDARY Number of Participants With Ischemia Driven Revascularizations |
150; 88 | — |
| SECONDARY Number of Participants With Ischemia Driven Revascularizations |
150; 88 | — |
| SECONDARY Number of Participants With Ischemia Driven Revascularizations |
150; 88 | — |
| SECONDARY Number of Participants With Ischemia Driven Revascularizations |
150; 88 | — |
| SECONDARY Number of Participants With Ischemia Driven Revascularizations |
150; 88 | — |
| SECONDARY Number of Participants With Ischemia Driven Revascularizations |
150; 88 | — |
| SECONDARY Number of Participants With All Revascularizations (Ischemia-driven or Non Ischemia-driven) |
3; 12 | — |
| SECONDARY Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) |
153; 92 | — |
| SECONDARY Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) |
153; 92 | — |
| SECONDARY Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) |
153; 92 | — |
| SECONDARY Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) |
153; 92 | — |
| SECONDARY Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) |
153; 92 | — |
| SECONDARY Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) |
153; 92 | — |
| SECONDARY Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) |
153; 92 | — |
| SECONDARY Percentage of Participants With Major Adverse Events (MAE) |
0.4; 1.3; 3.6; 6.2; 0.4; 1.4 | — |
| SECONDARY Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable |
0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable |
0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable |
3; 0; 1; 0 | — |
| SECONDARY Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable |
0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable |
3; 0; 1; 0 | — |
| SECONDARY Number of Participants With Graft Stenosis or Occlusion |
0; 58 | — |
| SECONDARY Number of Participants With Graft Stenosis or Occlusion |
0; 58 | — |
| SECONDARY Number of Participants With Graft Stenosis or Occlusion |
0; 58 | — |
| SECONDARY Number of Participants With Graft Stenosis or Occlusion |
0; 58 | — |
| SECONDARY Number of Participants With Graft Stenosis or Occlusion |
0; 58 | — |
| SECONDARY Number of Participants With Graft Stenosis or Occlusion |
0; 58 | — |
| SECONDARY Number of Participants With Graft Stenosis or Occlusion |
0; 58 | — |
| SECONDARY Number of Participants With Graft Stenosis or Occlusion |
0; 58 | — |
| SECONDARY Number of Participants With Requirement for Blood Product Transfusion |
52; 131 | — |
| SECONDARY Number of Participants With Requirement for Blood Product Transfusion |
52; 131 | — |
| SECONDARY Number of Participants With Requirement for Blood Product Transfusion |
52; 131 | — |
| SECONDARY Number of Participants With Requirement for Blood Product Transfusion |
52; 131 | — |
| SECONDARY Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding |
119; 137 | — |
| SECONDARY Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding |
119; 137 | — |
| SECONDARY Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding |
119; 137 | — |
| SECONDARY Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding |
119; 137 | — |
| SECONDARY Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding |
113; 153 | — |
| SECONDARY Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding |
113; 153 | — |
| SECONDARY Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding |
113; 153 | — |
| SECONDARY Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding |
113; 153 | — |
| SECONDARY Number of Participants With Major Adverse Events (MAE) |
9; 10; 37; 59; 6; 12 | — |
| SECONDARY Number of Participants With Complete Revascularization (Residual = 0) |
259; 10 | — |
| SECONDARY Number of Participants With Definite Stent Thrombosis (ST) or Symptomatic Graft Occlusion |
1; 11 | — |
| SECONDARY Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion |
10; 58 | — |
| SECONDARY Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion |
10; 58 | — |
| SECONDARY Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion |
10; 58 | — |
| SECONDARY Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion |
10; 58 | — |
| SECONDARY Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion |
10; 58 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01205776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.