Status:
COMPLETED
RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent.
Lead Sponsor:
Antwerp Cardiovascular Institute Middelheim
Conditions:
Stable Angina
Unstable Angina
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
Context: Sirolimus-eluting-stents have improved the benefits of percutaneous interventions in native coronary arteries reducing the occurrence of restenosis and repeated revascularization, however sap...
Eligibility Criteria
Inclusion
- 18 to 85 years-old
- clear signs and/or symptoms of stable or unstable angina or documented silent ischemia
- one or more de-novo target lesions (\>50% diameter stenosis by visual estimate) localized in one or more diseased SVG with a reference vessel diameter (RVD) included between 2.5 and 4.0 mm (by visual estimate)
- signed informed consent.
Exclusion
- Myocardial Infarction within the previous 7 days
- documented left ventricular ejection fraction \<25%
- impaired renal function (creatinine \>3.0 mg/dl) at the time of treatment
- outflow obstruction of the graft due to distal anastomotic stenosis
- totally occluded Saphenous Vein Graft
- brachytherapy treatment in the index vessel before enrollment
- life expectancy less than 12 months
- known allergy to aspirin, clopidogrel bisulfate, heparin, stainless steel, contrast agent or sirolimus
- hemorrhagic diatheses
- a recent positive pregnancy test, breast-feeding, or the possibility of a future pregnancy.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00263263
Start Date
September 1 2003
End Date
December 1 2005
Last Update
March 14 2007
Active Locations (1)
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1
Antwerp Cardiovascular Institute Middelheim
Antwerp, Belgium, 2020