Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis

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

3002 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this trial is to evaluate the efficacy of Rapamycin- and Zotarolimus-Eluting stents for the reduction of Coronary Restenosis

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Detailed Description

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This prospective, randomized trial will compare the efficacy and safety of a Rapamycin plus Probucol-eluting stent with a polymer based Zotarolimus-eluting stent. Patients with symptomatic coronary artery disease without cardiogenic shock who will undergo coronary angiography and willing to participate in the trial will receive a loading dose of 600mg clopidogrel at least 2 hours before the procedure. They will be randomized to receive one of the above mentioned stents.

Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dual-DES

Rapamycin + Probucol-eluting stent

Group Type EXPERIMENTAL

Rapamycin + Probucol-eluting stent (ISAR stent)

Intervention Type DEVICE

due to randomization, Rapamycin- + Probucol-eluting stent will be implanted

ZES

Polymer based Zotarolimus-eluting stent

Group Type ACTIVE_COMPARATOR

polymer based Zotarolimus-eluting stent (Endeavor Resolute)

Intervention Type DEVICE

due to randomization, Zotarolimus-eluting stent with polymer will be implanted

Interventions

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Rapamycin + Probucol-eluting stent (ISAR stent)

due to randomization, Rapamycin- + Probucol-eluting stent will be implanted

Intervention Type DEVICE

polymer based Zotarolimus-eluting stent (Endeavor Resolute)

due to randomization, Zotarolimus-eluting stent with polymer will be implanted

Intervention Type DEVICE

Other Intervention Names

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ISAR stent 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% de novo stenosis located in native coronary vessels
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
* In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion Criteria

* Target lesion located in the left main trunk.
* Target lesion located in the bypass graft.
* In-stent restenosis.
* Cardiogenic shock.
* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
* Known allergy to the study medications: Clopidogrel, Rapamycin, Probucol, Zotarolimus, stainless steel or cobalt chrome.
* Inability to take clopidogrel for at least 6 months.
* Pregnancy (present, suspected or planned) or positive pregnancy test.
* Previous enrollment in this trial.
* Patient's inability to fully cooperate with the study protocol.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No