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Clinical Trials/NCT00755443
NCT00755443
Completed
Phase 4

A Randomized Comparison of Sirolimus-Eluting Stent Versus Standard Stent for Percutaneous Coronary Revascularization in Diabetic Patients

Hospital San Carlos, Madrid1 site in 1 country160 target enrollmentStarted: February 2003Last updated:
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ConditionsCoronary Artery Disease

Overview

Phase
Phase 4
Status
Completed
Enrollment
160
Locations
1
Primary Endpoint
The primary endpoint of this study was in-segment late lumen loss as assessed by quantitative coronary angiography
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

The primary endpoint of this study was in-segment late lumen loss as assessed by quantitative coronary angiography

Time Frame: 270-day follow-up

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other

Study Sites (1)

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