Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT00151658

Collaborator

(none)

322

Enrollment

Location

Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischaemic Heart Disease	Device: Coronary Drug Eluting Stents for PCI	N/A

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2002

Study Completion Date :

Jun 1, 2006

Outcome Measures

Primary Outcome Measures

Minimal lumen diameter []
Frequency of restenosis (>50%) at 6 months. []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Patients:

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

Lesions:

Unprotected left main disease
Restenosis
Lesions containing visible thrombus
Treatment with other modality than balloon or stent (ablation, brachytherapy, ultrasound) in connection with the index procedure
Diffuse coronary disease distal to the treated lesion
Heavily calcification
Lesion located in saphenous vein graft