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

Prospective, Randomized Trial of Drug-eluting Stents vs. Bare Metal Stents for the Reduction of Restenosis in Bypass Grafts.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00611910

Acronym

ISAR-CABG

Enrollment

610

Registered

2008-02-11

Start date

2007-11-30

Completion date

2011-03-31

Last updated

2011-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriosclerosis of Arterial Coronary Artery Bypass Graft

Brief summary

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

Detailed description

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.

Interventions

DEVICEsirolimus-eluting stent

due to randomization Cypher stent will be implanted

DEVICEpaclitaxel-eluting stent

due to randomization Taxus stent will be implanted

DEVICEbiodegradable-polymer-based sirolimus-eluting stent

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

DEVICEbare metal stents

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The primary end point of the study is composite of death, myocardial infarction and target lesion revascularization at one year after stent implantation	12 months

Secondary

Measure	Time frame
Myocardial infarction rate	12 months
Need of target lesion revascularization (TLR), defined as any revascularization procedure involving the target lesion due to luminal re-narrowing in the presence of symptoms or objective signs of ischemia.	12 months
All cause death	12 months
Stent thrombosis	12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026