NCT00611910

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 610 (actual)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arteriosclerosis of Arterial Coronary Artery Bypass Graft

Interventions

Type	Name	Description
DEVICE	sirolimus-eluting stent	due to randomization Cypher stent will be implanted
DEVICE	paclitaxel-eluting stent	due to randomization Taxus stent will be implanted
DEVICE	biodegradable-polymer-based sirolimus-eluting stent	due to randomization a rapamycin-eluting stent with biodegradable polymer will be implanted
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

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2008-02-11
• Last updated: 2011-05-13

Locations

4 sites across 1 country: Germany