Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)

Not Applicable

Completed

• Conditions: Ischaemic Heart Disease

• Registration Number: NCT00151658
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Status Verified: 2005-09
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-09
• Last Update Submitted: 2005-09-12
• Last Update Posted: 2005-09-14
• Study Completion: 2006-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Minimal lumen diameter
Frequency of restenosis (>50%) at 6 months.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark