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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Drug eluting stent
Bare metal stent
Sponsored by
Hospital San Carlos, Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clinico San carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

2

1

Arm Description

Bare metal stent

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
September 18, 2008
Last Updated
September 18, 2008
Sponsor
Hospital San Carlos, Madrid
Collaborators
Hospital Clínico Universitario de Valladolid, Hospital Universitari de Bellvitge, Hospital de Meixoeiro
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1. Study Identification

Unique Protocol Identification Number
NCT00755443
Brief Title
Sirolimus-Eluting Stent Versus Standard Stent in Diabetic
Acronym
DIABETES
Official Title
A Randomized Comparison of Sirolimus-Eluting Stent Versus Standard Stent for Percutaneous Coronary Revascularization in Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital San Carlos, Madrid
Collaborators
Hospital Clínico Universitario de Valladolid, Hospital Universitari de Bellvitge, Hospital de Meixoeiro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Bare metal stent
Intervention Type
Device
Intervention Name(s)
Drug eluting stent
Intervention Description
Drug eluting stent implantation
Intervention Type
Device
Intervention Name(s)
Bare metal stent
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manel Sabate, Md, PhD
Organizational Affiliation
Hospital Clinico San Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinico San carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
16203930
Citation
Sabate M, Jimenez-Quevedo P, Angiolillo DJ, Gomez-Hospital JA, Alfonso F, Hernandez-Antolin R, Goicolea J, Banuelos C, Escaned J, Moreno R, Fernandez C, Fernandez-Aviles F, Macaya C; DIABETES Investigators. Randomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients: the diabetes and sirolimus-eluting stent (DIABETES) trial. Circulation. 2005 Oct 4;112(14):2175-83. doi: 10.1161/CIRCULATIONAHA.105.562421.
Results Reference
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Sirolimus-Eluting Stent Versus Standard Stent in Diabetic

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