NCT02099617

Efficacy and Safety of New Generation Drug Eluting Stents Associated With an Ultra Short Duration of Dual Antiplatelet Therapy. Design of the Short Duration of Dual antiplatElet Therapy With SyNergy II Stent in Patients Older Than 75 Years Undergoing Percutaneous Coronary Revascularization.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Ceric Sàrl · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the SENIOR study is to establish the efficacy and safety of the everolimus eluting stent with a biodegradable abluminal polymer (SYNERGY II) associated with a short dual antiplatelet therapy (DAPT) in patients ≥75 years old, suffering from stable angina, silent ischemia (1 month DAPT) or acute coronary syndromes (6 months DAPT) related to significant coronary artery disease and requiring percutaneous coronary intervention. The primary end point is to demonstrate that SYNERGY II in patients ≥75 years old is associated with a lower rate of the composite rate of major cardiovascular and cerebrovascular events (all-cause death, myocardial infarction, stroke, ischemia-driven target lesion revascularization) and a similar risk of stent thrombosis than bare metal stent at one year.

Conditions

• Stable Angina
• Silent Myocardial Ischemia
• Acute Coronary Syndrome

Interventions

Type	Name	Description
PROCEDURE	Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent
PROCEDURE	Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent
PROCEDURE	Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-07-01
• Completion: 2018-06-01
• First posted: 2014-03-31
• Last updated: 2024-01-16

Locations

44 sites across 9 countries: Belgium, Finland, France, Italy, Latvia, North Macedonia, Spain, Switzerland, United Kingdom