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Clinical Trials/NCT01182649
NCT01182649
Completed
Phase 3

Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With Coronary Artery Disease

San Giuseppe Moscati Hospital1 site in 1 country600 target enrollmentMarch 2007

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
San Giuseppe Moscati Hospital
Enrollment
600
Locations
1
Primary Endpoint
Target Vessel Revascularization
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in all comers PCI eligible patients

Detailed Description

Compared with the currently available first-generation drug-eluting stents (DES), second-generation DES have been designed with the goal of improving safety and efficacy. Everolimus, a sirolimus analogue, is released from a open cell, thin-strut, cobalt-chromium frame. A significant reduction in cardiac events was noted in patients with the everolimus-eluting stent compared with those who had a paclitaxel-eluting stent. Sirolimus eluting stent was the first available drug eluting stent and is the most tested. Therefore the investigators compared the safety and efficacy of the everolimus-eluting and sirolimus eluting stents in unselected patients in real world practice.

Registry
clinicaltrials.gov
Start Date
March 2007
End Date
June 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
San Giuseppe Moscati Hospital

Eligibility Criteria

Inclusion Criteria

  • All patients with coronary artery disease eligible for percutaneous coronary intervention (PCI)

Exclusion Criteria

  • Contraindication to dual antiplatelet therapy for 12 months
  • Known allergy to sirolimus or everolimus
  • Major surgical procedure planned within 1 month
  • History, symptoms, or findings suggestive of aortic dissection.
  • Participation in other trials
  • Pregnancy

Outcomes

Primary Outcomes

Target Vessel Revascularization

Time Frame: 2 year

Incidence of clinically driven target vessel revascularization at 2 year follow up

Secondary Outcomes

  • stent thrombosis(2 year)
  • non fatal myocardial infarction(2 year)
  • cardiac death(2 year)

Study Sites (1)

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