Randomized Multicenter Comparison of Sirolimus Versus Bare Metal Stent Implantation in Complex Coronary Lesions. Acronym: Scand Stent

Rigshospitalet, Denmark1 site in 1 country322 target enrollmentOctober 2002

ConditionsIschaemic Heart Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ischaemic Heart Disease
Sponsor: Rigshospitalet, Denmark
Enrollment: 322
Locations: 1
Primary Endpoint: Minimal lumen diameter
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary intervention.

Registry

clinicaltrials.gov

Start Date

October 2002

End Date

June 2006

Last Updated

20 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

•Stable, or unstable angina and/or objective signs of myocardial ischaemia Lesions should be de novo and located in native vessels with a diameter \> 2.25 mm.
•Complex lesions to be included should have at least one of the following characteristics:
•Ostial in location (\< 5 mm from ostium)
•Total occlusions with a length ≥ 15 mm
•Bifurcational (side branch \> 1.75 mm in diameter)
•Angulated (\> 45° within lesion)

Exclusion Criteria

•Other severe disease with an expected survival \< 1 year
•Other significant cardiac disease
•Known allergy against paclitaxel, clopidogrel or stainless steel.
•Myocardial infarction within 3 days of the index procedure
•Linguistic difficulties needing an interpreter
•Renal insufficiency (p-creatinine \> 200 micromol/l)
•Gastrointestinal bleeding within 1 month
•Childbearing potential or pregnancy
•Participation in another study
•Unprotected left main disease

Outcomes

Primary Outcomes

Minimal lumen diameter

Frequency of restenosis (>50%) at 6 months.

Secondary Outcomes

Diameter stenosis, late loss and loss index at 6 months MACE: death, myocardial infarction, target lesion revascularisation within 12 months and 24 months