Status:
COMPLETED
Cost-Effectiveness Study in the Reduction of Coronary Restenosis With Sirolimus-Eluting Stents
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Techniker Krankenkasse
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Since the advent of coronary stents, in-stent restenosis has proven to be the major limitation of interventional cardiology, occurring in as many as 30% of patients. Drug-eluting stents are specifical...
Eligibility Criteria
Inclusion
- indication for implantation of a coronary stent
- de novo lesions \< or = 30 mm in patients with diabetes
- de novo lesions 12-30 mm or RVD 2.5-3.00 mm in patients without diabetes
Exclusion
- acute MI
- lesion length \>30 mm
- in-stent restenosis
- distal lesion in RVD \< 2.25 mm
- lesion in left main or bypass vessel
- contraindication to Clopidogrel
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
958 Patients enrolled
Trial Details
Trial ID
NCT00627900
Start Date
April 1 2003
Last Update
March 4 2008
Active Locations (1)
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1
Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie
Berlin, Germany, 10098