Everolimus Stent in Patients With Coronary Artery Disease (CAD)

Phase 3

Completed

• Conditions: Coronary Artery Disease; Coronary Atherosclerosis
• Interventions: Device: stent; Device: coronary stent

• Registration Number: NCT01182649
• Lead Sponsor: San Giuseppe Moscati Hospital

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.

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-12
• Status Verified: 2010-05
• Study Completion: 2010-06
• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2010-08-16
• Last Update Submitted: 2010-08-16
• Study First Posted: 2010-08-17
• Last Update Posted: 2010-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SES Gruop	stent	Patients who received a sirolimus eluting stent
EES Group	coronary stent	Patients who received an everolimus eluting stent

Primary Outcome Measures

Name	Time	Method
Target Vessel Revascularization	2 year	Incidence of clinically driven target vessel revascularization at 2 year follow up

Secondary Outcome Measures

Name	Time	Method
stent thrombosis	2 year	incidence of definite, probable or possible stent thrombosis at 2 year
non fatal myocardial infarction	2 year	incidence of non fatal Q or non Q wave reinfarction at 2 year
cardiac death	2 year	incidence of death for cardiac causes at 2 year

Trial Locations

Locations (1)

Division of Cardiology Aorn Moscati; 🇮🇹 Avellino, Italy