Limus Eluted From A Durable Versus ERodable Stent Coating

NCT ID: NCT00389220

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1707 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2012-06-30

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.

Conditions

Coronary Disease; Coronary Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BioMatrix Flex stent

Coronary stent placement with Biolimus A9 coated stent with biodegradable polymer

Group Type: ACTIVE_COMPARATOR

Coronary stent placement

Intervention Type: DEVICE

Coronary stent placement

Cypher Select stent

Coronary stent placement with Sirolimus coated stent with durable polymer

Group Type: ACTIVE_COMPARATOR

Coronary stent placement

Intervention Type: DEVICE

Coronary stent placement

Interventions

Coronary stent placement

Coronary stent placement

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosensors Europe SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan Windecker, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern

Locations

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

Universitatsklinikum Munchen, Medizinische Klinik Kardiologie, Ziemssenstrasse 1

Munich, , Germany

Klinikum Bogenhausen der Stad München, Abteilung für Kardiologie und Pnemlogie, Englschalkstrasse 77

Munich, , Germany

University Medical Center Rotterdam Erasmus, Thoraxcentrum

Rotterdam, , Netherlands

American Heart of Poland Sp. z o.o.

Dąbrowa Górnicza, , Poland

Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern, Inselspital

Bern, , Switzerland

University Hospital Zürich, Director of Invasive Cardiology, Rämistrasse 100

Zurich, , Switzerland

Royal Brompton Hospital, Sydney Street

London, , United Kingdom

Countries

Belgium; France; Germany; Netherlands; Poland; Switzerland; United Kingdom

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Other Identifiers

05EU01

Identifier Type: -

Identifier Source: org_study_id