Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01080261 | PROMUS Element Japan Small Vessel Trial | PHASE3 | COMPLETED | 60 | — | — | Feb 1, 2010 | Dec 1, 2012 | Mar 29, 2016 | 15 | Japan |
| NCT00824434 | A Prospective, Multi-center Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) | PHASE3 | COMPLETED | 100 | — | — | Mar 1, 2009 | Aug 1, 2010 | Aug 30, 2012 | 17 | Australia, Malaysia +2 |
A major adverse cardiac event (MACE) is defined as any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI, Q-wave and non-Q-wave), or cardiac death. Reported as percentage of participants who have experienced a MACE event.
Percentage of patients who had a myocardial infarction, cardiac death, target lesion revascularization, or stent thrombosis (defined as definite or probable per the Academic Research Consortium \[ARC\] definitions); see below for definitions of individual components.
| Arm | Type | Description |
|---|---|---|
| PROMUS Element | EXPERIMENTAL | everolimus-eluting coronary stent |
| Experimental Stent | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PROMUS Element | DEVICE | PROMUS Element Everolimus-Eluting Coronary Stent System |
| PROMUS Element™ | DEVICE | Drug eluting coronary stent system |
Inclusion Criteria: * Patient must be at least 20 years of age * Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed * Patient is eligible for percutaneous coronary intervention (PC...