Status:
COMPLETED
Sirolimus-Eluting Stent Versus Standard Stent in Diabetic
Lead Sponsor:
Hospital San Carlos, Madrid
Collaborating Sponsors:
Hospital Clínico Universitario de Valladolid
Hospital Universitari de Bellvitge
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The purpose of this study was to determine whether Sirolimus stent implantation is effective in reducing neointimal hyperplasia as compared to Bare metal stent in diabetic patients with de novo corona...
Eligibility Criteria
Inclusion
- Diabetic either non-insulin or insulin-dependent (according to World Health Organization Report) on pharmacologic treatment (insulin or hypoglycaemic agents) for at least 1 month, and presented de novo coronary stenoses in 1,2 or 3 native vessels with symptoms or objective evidence of ischemia. Stenoses had to be amenable for stent implantation, with vessel size smaller than 4.0 mm (as assessed visually on angiography)
Exclusion
- Impaired glucose tolerance without pharmacologic treatment, gestational diabetes or transient hyperglycaemia
- Stenoses located in saphenous bypass, arterial bypass grafting, unprotected left main or involving important side branches (\> 2 mm) that should be treated during the procedure
- Left ventricle ejection fraction \< 25%
- Prior treatment with intracoronary brachytherapy or other drug eluting stent at target site
- Restenotic lesions; known allergies to aspirin, ticlopidine and clopidogrel acute coronary syndromes with persistent ST elevation \< 72 hours and/or CPK twice the upper normal limit
- Non-ST elevation acute coronary syndromes with CPK twice the upper normal limit
- Severe hepatic or renal disease (creatinin clearance \< 30 ml/min or hepatic enzymes twice the upper normal limit); and life expectancy \< 1 year
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00755443
Start Date
February 1 2003
End Date
December 1 2005
Last Update
September 19 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Clinico San carlos
Madrid, Madrid, Spain, 28040