Sirolimus-Eluting Stent Versus Standard Stent in Diabetic

Coronary Artery Disease Clinical Trial

— DIABETES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755443
• Other study ID #: DIABETES I TRIAL
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2008
• Last updated: September 18, 2008
• Start date: February 2003
• Est. completion date: December 2005

Study information

• Verified date: September 2008
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2005
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Drug eluting stent
Drug eluting stent implantation
• Bare metal stent

Locations

Country	Name	City	State
Spain	Hospital Clinico San carlos	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid	Hospital Clínico Universitario de Valladolid, Hospital de Meixoeiro, Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Sabaté M, Jiménez-Quevedo P, Angiolillo DJ, Gómez-Hospital JA, Alfonso F, Hernández-Antolín R, Goicolea J, Bañuelos C, Escaned J, Moreno R, Fernández C, Fernández-Avilés F, Macaya C; DIABETES Investigators. Randomized comparison of sirolimus-eluting stent — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of this study was in-segment late lumen loss as assessed by quantitative coronary angiography		270-day follow-up	No
Secondary	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	Yes