IMUS ELUTED FROM A DURABLE VERSUS ERODABLE STENT COATING - LEADERS

• Conditions: Coronary heart disease

• Registration Number: EUCTR2006-001540-31-NL
• Lead Sponsor: BIOSENSORS EUROPE SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1700

Inclusion Criteria

1.Age = 18 years
2.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
3.Presence of one or more coronary artery stenoses >50% in a native coronary artery or a saphenous bypass graft in a vessel with a reference diameter ranging from 2.25 to 4.0 mm which can be covered with one or multiple stents
4.No limitation to the number of treated lesions, number of vessels or lesion length but according to the randomization group.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnancy and breast feeding women
2. Known intolerance to aspirin, clopidogrel, heparin, stainless steel, sirolimus, biolimus, contrast material
3. Inability to provide informed consent
4.Currently participating in another trial before the first endpoint
5.Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period.

Due to the broad inclusion criteria (real world, all-comer” patients) enrollment of 80-90% of all patients undergoing percutaneous coronary intervention at each site is expected. A screening log will be kept at each site to assess how many eligible patients were actually included in the trial, and the monitor will be allowed to check the catheter lab diary.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified