Status:
COMPLETED
Sirolimus- and Paclitaxel-Eluting Stents for Small Vessels (ISAR-SMART-3)
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the efficacy of paclitaxel- and sirolimus-eluting stents to prevent re-blockage of small coronary arteries
Detailed Description
Although use of bare metal stents has reduced restenosis in coronary vessels with a diameter ≥3 mm when compared to plain balloon angioplasty, most of the dedicated randomized studies have failed to s...
Eligibility Criteria
Inclusion
- Stable or unstable angina pectoris and/or a positive stress test
- "de novo" lesion in small coronary arteries (vessel size \<2.8 mm by visual estimation)
- Written informed consent
Exclusion
- Diabetes mellitus
- Myocardial infarction within 48 h. before enrollment
- Target lesion located in the left main trunk or bypass graft
- Contraindication or known allergy to aspirin, thienopyridines, rapamycin, paclitaxel or stainless steel
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00146575
Start Date
June 1 2003
End Date
February 1 2005
Last Update
January 11 2008
Active Locations (2)
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1
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
2
Deutsches Herzzentrum
Munich, Germany, 80636