Drug-eluting Stents to Treat Unprotected Coronary Left Main Disease

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

PHASE4

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2013-02-28

Brief Summary

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The purpose of this study is to evaluate the efficacy of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) for treatment of unprotected left main coronary artery disease.

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Detailed Description

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Restenosis in the left main coronary artery may have severe consequences given the large proportion of the myocardium compromised in this condition, and, in several studies, it has been linked to the 6-month mortality after the index procedure. Drug-eluting stents have reduced the restenosis rate and the need for target vessel revascularization not only in simple lesion but also in high risk subsets of patients and lesions such as diabetics, long lesions or bifurcations. There are no data about their efficacy in left main coronary artery disease. Thus, the aim of this study is to investigate the performance of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) in left main coronary lesions.

Conditions

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Coronary Disease

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

Everolimus-eluting stent (Xience)

Group Type ACTIVE_COMPARATOR

Everolimus-eluting stent (Xience)

Intervention Type DEVICE

stent is implanted due to randomization

ZES

Zotarolimus-eluting stent (Endeavor Resolute)

Group Type EXPERIMENTAL

Zotarolimus-eluting stent (Endeavor Resolute)

Intervention Type DEVICE

stent is implanted due to randomization

Interventions

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Everolimus-eluting stent (Xience)

stent is implanted due to randomization

Intervention Type DEVICE

Zotarolimus-eluting stent (Endeavor Resolute)

stent is implanted due to randomization

Intervention Type DEVICE

Other Intervention Names

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Xience Endeavor Resolute

Eligibility Criteria

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Inclusion Criteria

* Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50 % stenosis located in unprotected LMCA who are unable to undergo CABG because of cardiac surgeons' refusal (poor surgical candidates) or their own unwillingness.
* Pretreatment with a loading dose of 600 mg clopidogrel.
* Informed, written consent by the patients or her/his legally-authorized representative for participation in the study.

Exclusion Criteria

* Cardiogenic shock.
* ST-segment elevation acute myocardial infarction (ST-segment ≥ 0.1 mV elevation in ≥ 2 contiguous ECG leads persisting for at least 20 minutes) within 48 hours from symptom onset.
* In-stent restenosis.
* Malignancies or other comorbid conditions with life expectancy less than one year or that may result in protocol non-compliance.
* Prior coronary artery bypass surgery with revascularization of LAD and/or LCx.
* Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days.
* An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first six months post enrollment.
* Known allergy to the study medications: aspirin, clopidogrel, UHF; sirolimus, paclitaxel; true anaphylaxis after prior exposure to contrast media.
* Pregnancy (present, suspected or planned).
* Patient's inability to fully cooperate with the study protocol.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No