Clinical trial NCT00389220: Limus Eluted From A Durable Versus ERodable Stent Coating
Official title: A Randomized Comparison of a Biolimus-Eluting Stent With a Sirolimus-Eluting Stent for Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Coronary Stenosis
Keywords: Coronary Disease
Coronary Stenosis
Angioplasty
Coronary Restenosis
Drug Eluting Stent
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
First posted: 2006-10-18
Enrollment: 1707
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
timeFrame: 9 month
Secondary outcomes:
measure: Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
timeFrame: 30 days
measure: Cardiac death
timeFrame: 30 days
measure: All deaths
timeFrame: 30 days
measure: Myocardial infarction
timeFrame: 30 days
measure: Angiographic and clinical stent thrombosis.
timeFrame: 30 days
measure: In-stent and in-segment binary restenosis rate as assessed by QCA.
timeFrame: 9 month
measure: In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA.
timeFrame: 9 month
measure: In-segment percent diameter stenosis (%DS).
timeFrame: 9 month
measure: In-stent and in-segment late luminal loss
timeFrame: 9 month
measure: Device success, lesion success and procedural success.
timeFrame: at implant
measure: Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
timeFrame: 6 month
measure: Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
timeFrame: 1 year
measure: Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
timeFrame: 2 years
measure: Cardiac death
timeFrame: 6 month
measure: Cardiac death
timeFrame: 9 month
measure: Cardiac death
timeFrame: 1 year
measure: Cardiac death
timeFrame: 2 year
measure: Cardiac death
timeFrame: 3 year
measure: Cardiac death
timeFrame: 4 year
measure: Cardiac death
timeFrame: 5 year
measure: Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
timeFrame: 3 year
measure: Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
timeFrame: 4 year
measure: Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
timeFrame: 5 year
measure: All deaths
timeFrame: 6 month
measure: All deaths
timeFrame: 9 month
measure: All deaths
timeFrame: 1 year
measure: All deaths
timeFrame: 2 years
measure: All deaths
timeFrame: 3 years
measure: All deaths
timeFrame: 4 years
measure: All deaths
timeFrame: 5 years
measure: Myocardial infarction
timeFrame: 6 month
measure: Myocardial infarction
timeFrame: 9 month
measure: Myocardial infarction
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 2 years
measure: Myocardial infarction
timeFrame: 3 years
measure: Myocardial infarction
timeFrame: 4 years
measure: Myocardial infarction
timeFrame: 5 years
measure: Angiographic and clinical stent thrombosis.
timeFrame: 6 month
measure: Angiographic and clinical stent thrombosis.
timeFrame: 9 month
measure: Angiographic and clinical stent thrombosis.
timeFrame: 1 year
measure: Angiographic and clinical stent thrombosis.
timeFrame: 2 years
measure: Angiographic and clinical stent thrombosis.
timeFrame: 3 years
measure: Angiographic and clinical stent thrombosis.
timeFrame: 4 years
measure: Angiographic and clinical stent thrombosis.
timeFrame: 5 years
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis, Cardiologisch Centrum, Moorselbaan 164
city: Massy
country: France
facility: L'Institut Cardiovasculaire Paris Sud, Institut Hospitalier Jacques Cartier, Service de Coronarographie, 6, Avenue du Noyer Lambert
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig, Innere Medizin/Kardiologie, Struimpellstrasse 39
city: Munich
country: Germany
facility: Universitatsklinikum Munchen, Medizinische Klinik Kardiologie, Ziemssenstrasse 1
city: Munich
country: Germany
facility: Klinikum Bogenhausen der Stad München, Abteilung für Kardiologie und Pnemlogie, Englschalkstrasse 77
city: Rotterdam
country: Netherlands
facility: University Medical Center Rotterdam Erasmus, Thoraxcentrum
city: Dąbrowa Górnicza
country: Poland
facility: American Heart of Poland Sp. z o.o.
city: Bern
country: Switzerland
facility: Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern, Inselspital
city: Zurich
country: Switzerland
facility: University Hospital Zürich, Director of Invasive Cardiology, Rämistrasse 100
city: London
country: United Kingdom
facility: Royal Brompton Hospital, Sydney Street
Study officials:
affiliation: Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern
name: Stephan Windecker, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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