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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03350542 | A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s) | PHASE3 | COMPLETED | 100 | — | — | Apr 12, 2018 | Jan 8, 2021 | May 14, 2021 | 15 | United States, Latvia +2 |
The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
| Arm | Type | Description |
|---|---|---|
| SYNERGY 48 mm | EXPERIMENTAL | SYNERGY 48 mm 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 |
|---|---|---|
| SYNERGY 48 mm | DEVICE | A drug eluting coronary stent system |
Clinical 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 * Subject is eligible for percutaneo...