Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)

Rigshospitalet

Status: Completed

Conditions: Ischaemic Heart Disease

Treatments: Device: Coronary Drug Eluting Stents for PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT00151658

SCANDSTENT

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)