Everolimus Stent in Patients With Coronary Artery Disease (CAD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Coronary Artery Disease Coronary Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EES Group

Patients who received an everolimus eluting stent

Group Type EXPERIMENTAL

coronary stent

Intervention Type DEVICE

coronary angioplasty with stent implantation

SES Gruop

Patients who received a sirolimus eluting stent

Group Type ACTIVE_COMPARATOR

stent

Intervention Type DEVICE

coronary angioplasty with stent implantation

Interventions

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coronary stent

coronary angioplasty with stent implantation

Intervention Type DEVICE

stent

coronary angioplasty with stent implantation

Intervention Type DEVICE

Other Intervention Names

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XIENCE V drug eluting stent; Abbot Vascular USA CYPHER drug eluting stent; Johnson & Johnson USA

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No