Status:
COMPLETED
Oral Sirolimus for In-Stent Restenosis
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Coronary Restenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Despite recent advances in interventional cardiology including the success of drug-eluting stents in de-novo coronary lesions, the treatment of in-stent restenosis remains a challenging clinical issue...
Detailed Description
Three-hundred symptomatic patients with in-stent restenotic lesions were randomly assigned to one of three treatment arms: placebo, usual dose or high dose sirolimus. Patients received a cumulative lo...
Eligibility Criteria
Inclusion
- Patients with angina pectoris or exercise-induced ischemia in the presence of angiographically significant in-stent-restenosis in native coronary arteries.
Exclusion
- Patients with acute coronary syndromes or with severe infectious diseases the presence of severe kidney failure (serum creatinine \> 2.2 mg/dl) contraindications to sirolimus
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00859183
Start Date
October 1 2001
End Date
March 1 2004
Last Update
March 10 2009
Active Locations (3)
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1
Medizinische Klinik I, Garmisch-Partenkirchen
Garmisch-Partenkirchen, Germany
2
Deutsches Herzzentrum
Munich, Germany, 80636
3
1. Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675