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

Arteriosclerosis of Arterial Coronary Artery Bypass Graft Clinical Trial

— ISAR-CABG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611910
• Other study ID #: GE IDE No. S02707
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2008
• Last updated: May 12, 2011
• Start date: November 2007
• Est. completion date: March 2011

Study information

• Verified date: May 2011
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Arteriosclerosis of Arterial Coronary Artery Bypass Graft

Intervention

Device:
• sirolimus-eluting stent
due to randomization Cypher stent will be implanted
• paclitaxel-eluting stent
due to randomization Taxus stent will be implanted
• biodegradable-polymer-based sirolimus-eluting stent
due to randomization a rapamycin-eluting stent with biodegradable polymer will be implanted
• 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

Locations

Country	Name	City	State
Germany	Herzzentrum Bad Krozingen	Bad Krozingen
Germany	Bad Segeberger Kliniken	Bad Segeberg
Germany	Medizinische Klinik, Klinikum rechts der Isar	Muenchen
Germany	Deutsches Herzzentrum Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Myocardial infarction rate		12 months	Yes
Secondary	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	No
Secondary	All cause death		12 months	Yes
Secondary	Stent thrombosis		12 months	Yes