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Completed

NCT Number: NCT01289002

e-BioMatrix PostMarket Registry

The purpose of this registry is to capture clinical data of the BioMatrix™ and BioMatrix Flex™ (Biolimus A9™-Eluting) stent systems in relation to safety and effectiveness.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universität Innsbruck, Innsbruck, Austria

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About this study

Prospective, multi-center registry to be conducted at 60-70 international interventional cardiology centers. All patients will be followed for up to 3 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Patients that need a treatment with either a BioMatrix™ or a BioMatrix Flex™ drug-eluting stent
  • Presence of one or more coronary artery stenoses in a native coronary artery or a saphenous bypass graft from 2.25 to 4.0 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

  • Inability to provide informed consent
  • Patients needing additional stent NOT of the Biolimus A9™-eluting stent type
  • Patients receiving next to the Biolimus A9™-eluting stent also other coronary vascular interventions, for example dilation
  • Patients receiving both the BioMatrix™ and the BioMatrix Flex™ stent during index and/or staged procedure

Treatment and study plan

Primary outcomes

  1. MACE

    Time frame: 12 months

    Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization at 12 months.

Secondary outcomes

  1. stent thrombosis

    Time frame: 30 days, 6 and 12 months, 2, 3 and 5 years

    Primary and secondary stent thrombosis (definite and probable according to ARC definitions) at 30 days, 6 and 12 months, 2, 3 and 5 years;

  2. MACE

    Time frame: 30 days, 6 months, 2, 3 and 5 years;

    Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization at 30 days, 6 months, 2, 3 and 5 years;

  3. Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any clinically driven target vessel revascularization at 30 days, 6 and 12 months, 2, 3 and 5 years;

    Time frame: 6 and 12 months, 2, 3 and 5 years

  4. Death and MI at 30 days, 6 and 12 months, 2, 3 and 5 years;

    Time frame: 30 days, 6 and 12 months, 2, 3 and 5 years;

  5. Death and post-procedural MI at 30 days, 6 and 12 months, 2, 3 and 5 years;

    Time frame: 30 days, 6 and 12 months, 2, 3 and 5 years

  6. Total revascularization rate (clinically and non clinically driven) at 30 days, 6 and 12 months, 2, 3 and 5 years.

    Time frame: 30 days, 6 and 12 months, 2, 3 and 5 years.

Sponsors and collaborators

Lead sponsor

Biosensors Europe SA

Industry

Registry information

Official study title

A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.

Acronym: eBMX-PMR

Important dates

Study start
2008
Primary completion
2012
Study completion
2014
First posted
Feb 3, 2011
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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