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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01665053 | The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s) | PHASE3 | COMPLETED | 1,684 | — | — | Nov 1, 2012 | Dec 22, 2018 | Jan 30, 2019 | 126 | United States, Australia +14 |
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
| Arm | Type | Description |
|---|---|---|
| Promus Element Plus | ACTIVE_COMPARATOR | PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating). |
| SYNERGY | EXPERIMENTAL | SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating). |
| Name | Type | Description |
|---|---|---|
| PROMUS Element Plus | DEVICE | A drug eluting coronary stent system |
| SYNERGY | DEVICE | A drug eluting coronary stent system |
Inclusion Criteria: * Subject must be at least 18 years of age * Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed * For subjects less than 20 years of age enr...