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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.

NCT02099617 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2024-01-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Ceric Sàrl

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-07-31
Completion
2018-06-30

Countries

  • Belgium
  • Finland
  • France
  • Italy
  • Latvia
  • North Macedonia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02099617 on ClinicalTrials.gov