Sirolimus-Eluting Stent Versus Standard Stent in Diabetic (DIABETES)

This study has been completed.
Sponsor:
Collaborators:
Hospital Clinico of Valladolid
Hospital Universitari de Bellvitge
Hospital de Meixoeiro
Information provided by:
Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:
NCT00755443
First received: September 18, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: Drug eluting stent
Device: Bare metal stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Sirolimus-Eluting Stent Versus Standard Stent for Percutaneous Coronary Revascularization in Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Hospital San Carlos, Madrid:

Primary Outcome Measures:
  • The primary endpoint of this study was in-segment late lumen loss as assessed by quantitative coronary angiography [ Time Frame: 270-day follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 160
Study Start Date: February 2003
Study Completion Date: December 2005
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 Device: Drug eluting stent
Drug eluting stent implantation
Placebo Comparator: 1
Bare metal stent
Device: Bare metal stent

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00755443

Locations
Spain
Hospital Clinico San carlos
Madrid, Spain, 28040
Sponsors and Collaborators
Hospital San Carlos, Madrid
Hospital Clinico of Valladolid
Hospital Universitari de Bellvitge
Hospital de Meixoeiro
Investigators
Principal Investigator: Manel Sabate, Md, PhD Hospital Clinico San Carlos
  More Information

Publications:
Responsible Party: Manel Sabate, Hospital Clinico San Carlos
ClinicalTrials.gov Identifier: NCT00755443     History of Changes
Other Study ID Numbers: DIABETES I TRIAL
Study First Received: September 18, 2008
Last Updated: September 18, 2008
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014