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Completed

NCT Number: NCT01254487

e-BioMatrix PostMarket Surveillance Registry

The purpose of the e-BioMatrix PMS registry is to capture clinical data of the BioMatrix (Biolimus A9-Eluting) stent system 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

Arrixaca University Hospital, Murcia, Spain

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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 a BioMatrix™ 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 BioMatrix™ type
  • Patients receiving next to the BioMatrix™ stent also other coronary vascular interventions, for example dilation.

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: 12 Months

Secondary outcomes

  1. Primary and secondary stent thrombosis (definite and probable according to ARC definitions)

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

  2. 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

    Time frame: 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

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

  4. Death and MI

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

  5. Total revascularization rate (clinically and non clinically driven)

    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 Surveillance Registry of the BioMatrix Drug-eluting Stent

Important dates

Study start
2008
Primary completion
2012
Study completion
2014
First posted
Dec 6, 2010
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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