Limus Eluted From A Durable Versus ERodable Stent Coating

Not Applicable

Completed

• Conditions: Coronary Stenosis; Coronary Disease
• Interventions: Device: Coronary stent placement

• Registration Number: NCT00389220
• Lead Sponsor: Biosensors Europe SA

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.

Study Timeline

• Study First Submitted: 2006-10-13
• Study First Submitted QC: 2006-10-13
• Study First Posted: 2006-10-18
• Study Start: 2006-11
• Primary Completion: 2008-05
• Study Completion: 2012-06
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1707

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BioMatrix Flex stent	Coronary stent placement	Coronary stent placement with Biolimus A9 coated stent with biodegradable polymer
Cypher Select stent	Coronary stent placement	Coronary stent placement with Sirolimus coated stent with durable polymer

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.	9 month	Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)

Secondary Outcome Measures

Name	Time	Method
Cardiac death	5 year	Cardiac death
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.	5 year	Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA.	9 month	In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA
All deaths	5 years	All deaths (cardiac and non-cardiac)
In-stent and in-segment binary restenosis rate as assessed by QCA.	9 month	In-stent and in-segment binary restenosis rate as assessed by QCA.
In-stent and in-segment late luminal loss	9 month	In-stent and in-segment late luminal loss as assessed by QCA
Myocardial infarction	5 years	Myocardial infarction (Q-wave and NQWMI)
In-segment percent diameter stenosis (%DS).	9 month	In-segment percent diameter stenosis (%DS) as assessed by QCA
Device success, lesion success and procedural success.	at implant
Angiographic and clinical stent thrombosis.	5 years	Angiographic and clinical stent thrombosis

Trial Locations

Locations (10)

Onze Lieve Vrouw Ziekenhuis, Cardiologisch Centrum, Moorselbaan 164; 🇧🇪 Aalst, Belgium

L'Institut Cardiovasculaire Paris Sud, Institut Hospitalier Jacques Cartier, Service de Coronarographie, 6, Avenue du Noyer Lambert; 🇫🇷 Massy, France

Herzzentrum Leipzig, Innere Medizin/Kardiologie, Struimpellstrasse 39; 🇩🇪 Leipzig, Germany

Klinikum Bogenhausen der Stad München, Abteilung für Kardiologie und Pnemlogie, Englschalkstrasse 77; 🇩🇪 Munich, Germany

Universitatsklinikum Munchen, Medizinische Klinik Kardiologie, Ziemssenstrasse 1; 🇩🇪 Munich, Germany

University Medical Center Rotterdam Erasmus, Thoraxcentrum; 🇳🇱 Rotterdam, Netherlands

University Hospital Zürich, Director of Invasive Cardiology, Rämistrasse 100; 🇨🇭 Zurich, Switzerland

Royal Brompton Hospital, Sydney Street; 🇬🇧 London, United Kingdom

American Heart of Poland Sp. z o.o.; 🇵🇱 Dąbrowa Górnicza, Poland

Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern, Inselspital; 🇨🇭 Bern, Switzerland