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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01787799 | EVOLVE II QCA: A Prospective, Multicenter Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s) | PHASE3 | COMPLETED | 100 | — | — | Mar 1, 2013 | Oct 1, 2014 | Mar 16, 2016 | 13 | Australia, Japan +2 |
In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA)
| Arm | Type | Description |
|---|---|---|
| SYNERGY Stent System | EXPERIMENTAL | SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) |
| Name | Type | Description |
|---|---|---|
| SYNERGY | DEVICE | Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating. |
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...