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SYNERGY · 1 trial · 1 indication
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...
SYNERGY is a stent system developed by Boston Scientific Corporation for the treatment of atherosclerotic lesions, which are areas of plaque buildup in arteries. It is intended to address blockages caused by atherosclerosis, a cardiovascular condition. The device is designed to be implanted to help restore blood flow in affected vessels.
SYNERGY is developed by Boston Scientific Corporation, a medical device company traded on the New York Stock Exchange under the ticker BSX. The company is responsible for the research, development, and clinical evaluation of the SYNERGY stent system for treating atherosclerotic lesions.
SYNERGY is in Phase 3 clinical development. The device has completed a Phase 3 trial, meaning it is in the later stages of clinical investigation. It is not yet approved for commercial use and remains an investigational product under evaluation for the treatment of atherosclerotic lesions.
SYNERGY has one completed Phase 3 clinical trial registered under NCT01787799, titled "EVOLVE II QCA: A Prospective, Multicenter Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)." The trial enrolled 100 participants and was conducted in Australia, Japan, New Zealand, and Singapore.
SYNERGY is not FDA approved. It is an investigational device currently in Phase 3 clinical development. The completed trial, NCT01787799, evaluated the stent system for atherosclerotic lesions, but the product has not yet received regulatory approval for commercial use in the United States or elsewhere.