Limus Eluted From A Durable Versus ERodable Stent Coating (LEADERS)

Biosensors International

Status

Completed

Conditions

Coronary Disease

Coronary Stenosis

Treatments

Device: Coronary stent placement

Study type

Interventional

Funder types

Industry

Identifiers

NCT00389220

05EU01

Details and patient eligibility

About

The purpose of this study is to compare the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a non-inferiority trial.

Full description

Compare the safety and efficacy of the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a prospective, multi-center, randomized, controlled, non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.

Enrollment

1,707 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age >= 18 years;
Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction and ST-elevation myocardial infarction;
Presence of one or more coronary artery stenoses >50% in a native coronary artery or a saphenous bypass graft from 2.25 to 3.5 mm in diameter that can be covered with one or multiple stents;
No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion criteria

Pregnancy;
Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Biolimus or contrast material;
Inability to provide informed consent;
Currently participating in another trial before reaching first endpoint;
Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the perisurgical period