NCT00598637

Drug-eluting Stents to Treat Unprotected Coronary Left Main Disease

Prospective Randomized Trial of Everolimus- and Zotarolimus-eluting Stents for Treatment of Unprotected Left Main Coronary Artery Disease: ISAR-LEFT-MAIN-2

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 650 (actual)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) for treatment of unprotected left main coronary artery disease.

Detailed description

Restenosis in the left main coronary artery may have severe consequences given the large proportion of the myocardium compromised in this condition, and, in several studies, it has been linked to the 6-month mortality after the index procedure. Drug-eluting stents have reduced the restenosis rate and the need for target vessel revascularization not only in simple lesion but also in high risk subsets of patients and lesions such as diabetics, long lesions or bifurcations. There are no data about their efficacy in left main coronary artery disease. Thus, the aim of this study is to investigate the performance of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) in left main coronary lesions.

Conditions

• Coronary Disease

Interventions

Type	Name	Description
DEVICE	Everolimus-eluting stent (Xience)	stent is implanted due to randomization
DEVICE	Zotarolimus-eluting stent (Endeavor Resolute)	stent is implanted due to randomization

Timeline

• Start date: 2007-12-01
• Primary completion: 2012-09-01
• Completion: 2013-02-01
• First posted: 2008-01-22
• Last updated: 2013-07-02

Locations

4 sites across 2 countries: Germany, Italy