NCT00598533

Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis

Prospective, Randomized Trial of Rapamycin- and Zotarolimus-eluting Stents for the Reduction of Coronary Restenosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,002 (actual)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to evaluate the efficacy of Rapamycin- and Zotarolimus-Eluting stents for the reduction of Coronary Restenosis

Detailed description

This prospective, randomized trial will compare the efficacy and safety of a Rapamycin plus Probucol-eluting stent with a polymer based Zotarolimus-eluting stent. Patients with symptomatic coronary artery disease without cardiogenic shock who will undergo coronary angiography and willing to participate in the trial will receive a loading dose of 600mg clopidogrel at least 2 hours before the procedure. They will be randomized to receive one of the above mentioned stents.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DEVICE	Rapamycin + Probucol-eluting stent (ISAR stent)	due to randomization, Rapamycin- + Probucol-eluting stent will be implanted
DEVICE	polymer based Zotarolimus-eluting stent (Endeavor Resolute)	due to randomization, Zotarolimus-eluting stent with polymer will be implanted

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-08-01
• Completion: 2010-09-01
• First posted: 2008-01-22
• Last updated: 2012-01-05

Locations

2 sites across 1 country: Germany