Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SYNERGY 48 mm · 1 trial · 1 indication
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...
SYNERGY 48 mm is an investigational stent system being studied for the treatment of coronary artery disease. It is designed to treat atherosclerotic lesions in patients with this condition. The device is currently in Phase 3 clinical development and is not yet approved for commercial use.
SYNERGY 48 mm is developed by Boston Scientific Corporation, a medical device company traded on the New York Stock Exchange under the ticker symbol BSX. The company is conducting clinical trials to evaluate the safety and effectiveness of this stent system for coronary artery disease.
SYNERGY 48 mm is in Phase 3 clinical development. It is an investigational device, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials. The Phase 3 study has been completed, but the device remains under investigation.
SYNERGY 48 mm has one completed Phase 3 clinical trial registered as NCT03350542, titled "A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s)." The trial enrolled 100 participants with coronary artery disease across the United States, Latvia, New Zealand, and the United Kingdom.
SYNERGY 48 mm is not FDA approved. It is an investigational device currently in Phase 3 clinical development. The completed clinical trial, NCT03350542, evaluated the stent system in 100 patients with coronary artery disease, but regulatory approval has not been granted.