NCT00755443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Feb 2003

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2008

Completed
Last Updated

September 19, 2008

Status Verified

September 1, 2008

Enrollment Period

1.6 years

First QC Date

September 18, 2008

Last Update Submit

September 18, 2008

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

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

    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

    1, 9, 12 and 24-month follow-up

Study Arms (2)

2

EXPERIMENTAL
Device: Drug eluting stent

1

PLACEBO COMPARATOR

Bare metal stent

Device: Bare metal stent

Interventions

Drug eluting stentDEVICE

Drug eluting stent implantation

2
Bare metal stentDEVICE
1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico San carlos

Madrid, Madrid, 28040, Spain

Location

Related Publications (1)

  • 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.

    PMID: 16203930RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Manel Sabate, Md, PhD

    Hospital Clinico San Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2008

First Posted

September 19, 2008

Study Start

February 1, 2003

Primary Completion

September 1, 2004

Study Completion

December 1, 2005

Last Updated

September 19, 2008

Record last verified: 2008-09

Locations

ES(1)