Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease

Rigshospitalet

Status

Unknown

Conditions

Coronary Artery Disease

Treatments

Device: Bx Sonic & Cypher stent from Cordis

Study type

Interventional

Funder types

Other

Identifiers

NCT00192881

SCANDSTENT A

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
Informed consent
Optimal result (< 35% residual stenosis and < type C dissection) after balloon angioplasty
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 ticlopidine),
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