Efficacy Study of Drug-eluting and Bare Metal Stents in Bypass Graft Lesions

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

610 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-03-31

Brief Summary

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The aim of this study is to compare the efficacy of drug-eluting stents and bare metal stents to reduce reblockage of bypass grafts after coronary stenting

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Detailed Description

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A large number of studies showed that drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare metal stents. Although this applies to the vast majority of patients, intimal hyperplasia and in-stent restenosis have not been completely eliminated and remain to occur in certain high risk subgroups. While there is a plenty of data about the efficacy of DES in complex lesions or diabetics, no randomized data exist about the efficacy of DES in coronary artery bypass graft lesions.

Conditions

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Arteriosclerosis of Arterial Coronary Artery Bypass Graft

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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DES

drug-eluting stents

Group Type EXPERIMENTAL

sirolimus-eluting stent

Intervention Type DEVICE

due to randomization Cypher stent will be implanted

paclitaxel-eluting stent

Intervention Type DEVICE

due to randomization Taxus stent will be implanted

biodegradable-polymer-based sirolimus-eluting stent

Intervention Type DEVICE

due to randomization a rapamycin-eluting stent with biodegradable polymer will be implanted

BMS

bare metal stents

Group Type ACTIVE_COMPARATOR

bare metal stents

Intervention Type DEVICE

Due to randomization one bare-metal stent will be implanted. The decision about the stent type will be up to the interventionalist

Interventions

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sirolimus-eluting stent

due to randomization Cypher stent will be implanted

Intervention Type DEVICE

paclitaxel-eluting stent

due to randomization Taxus stent will be implanted

Intervention Type DEVICE

biodegradable-polymer-based sirolimus-eluting stent

due to randomization a rapamycin-eluting stent with biodegradable polymer will be implanted

Intervention Type DEVICE

bare metal stents

Due to randomization one bare-metal stent will be implanted. The decision about the stent type will be up to the interventionalist

Intervention Type DEVICE

Other Intervention Names

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Cypher Taxus ISAR-DES, Yukon PC Multilink Vision Driver etc.

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 CABG
* 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

* Cardiogenic shock
* Target lesion located in the native coronary vessels.
* In-stent restenosis of CABG
* Target lesion located at internal mammary artery graft or free arterial graft
* 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, paclitaxel, stainless steel.
* 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