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OpenTrials
Completed

NCT Number: NCT00755443

Sirolimus-Eluting Stent Versus Standard Stent in Diabetic

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.

Completed

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinico San carlos

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug eluting stent

Device

Drug eluting stent implantation

Bare Metal Stent

Device

Primary outcomes

  1. 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

  1. 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

    Time frame: 1, 9, 12 and 24-month follow-up

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Collaborators

  • Hospital Clínico Universitario de Valladolid
  • Hospital Universitari de Bellvitge
  • Hospital de Meixoeiro

Registry information

Official study title

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

Acronym: DIABETES

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Sep 19, 2008
Registry last updated
Sep 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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