Status:
COMPLETED
Nonpolymer- and Polymer-Based Drug-Eluting Stents for Restenosis (ISAR-TEST-1)
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Collaborating Sponsors:
Bayerische Forschungsstiftung Muenchen
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the efficacy of nonpolymer-based rapamycin-eluting stent compared to standard polymer-based paclitaxel-eluting stent to reduce reblockage of coronary arteries.
Detailed Description
Drug-eluting stents represent a major advance in the treatment of restenosis. They have dramatically reduced the need of repeat revascularization procedures, and, thanks to the excellent results obtai...
Eligibility Criteria
Inclusion
- Patients at least 18 years old
- Stable or unstable angina or a positive stress test
- "de novo" coronary artery lesions
- Written informed consent
Exclusion
- Myocardial infarction within 48 h. before enrollment
- Target lesion located in left main trunk
- Contraindication or known allergy to aspirin, heparin, thienopyridines, rapamycin, paclitaxel or stainless steel
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00140530
Start Date
March 1 2004
End Date
June 1 2005
Last Update
January 11 2008
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
2
First Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675