Sirolimus-Eluting Stent Versus Standard Stent in Diabetic

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Bare metal stent; Device: Drug eluting stent

• Registration Number: NCT00755443
• Lead Sponsor: Hospital San Carlos, Madrid

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 coronary artery stenosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2004-09
• Study Completion: 2005-12
• Status Verified: 2008-09
• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-18
• Last Update Submitted: 2008-09-18
• Study First Posted: 2008-09-19
• Last Update Posted: 2008-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Bare metal stent	Bare metal stent
2	Drug eluting stent	-

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study was in-segment late lumen loss as assessed by quantitative coronary angiography	270-day follow-up

Secondary Outcome Measures

Name	Time	Method
Other angiographic parameters of restenosis such as binary restenosis, and minimal luminal diameter; major adverse cardiac events including cardiac death, myocardial infarction, target lesion (in-segment zone) revascularization stent thrombosis	1, 9, 12 and 24-month follow-up

Trial Locations

Locations (1)

Hospital Clinico San carlos; 🇪🇸 Madrid, Spain