e-BioMatrix PostMarket Registry (eBMX-PMR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biosensors Europe SA
ClinicalTrials.gov Identifier:
NCT01289002
First received: February 2, 2011
Last updated: January 1, 2013
Last verified: January 2013
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.

Resource links provided by NLM:


Further study details as provided by Biosensors Europe SA:

Primary Outcome Measures:
  • MACE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • stent thrombosis [ Time Frame: 30 days, 6 and 12 months, 2, 3 and 5 years ] [ Designated as safety issue: Yes ]
    Primary and secondary stent thrombosis (definite and probable according to ARC definitions) at 30 days, 6 and 12 months, 2, 3 and 5 years;

  • MACE [ Time Frame: 30 days, 6 months, 2, 3 and 5 years; ] [ Designated as safety issue: Yes ]
    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;

  • 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 ] [ Designated as safety issue: Yes ]
  • 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; ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4000
Study Start Date: April 2008
Estimated Study Completion Date: September 2016
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Prospective, multi-center registry to be conducted at 60-70 international interventional cardiology centers. All patients will be followed for up to 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

"Real world, all comer" patients

Criteria

Inclusion Criteria:

  1. Age ≥18 years
  2. Patients that need a treatment with either a BioMatrix™ or a BioMatrix Flex™ drug-eluting stent
  3. 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
  4. No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion Criteria:

  1. Inability to provide informed consent
  2. Patients needing additional stent NOT of the Biolimus A9™-eluting stent type
  3. Patients receiving next to the Biolimus A9™-eluting stent also other coronary vascular interventions, for example dilation
  4. Patients receiving both the BioMatrix™ and the BioMatrix Flex™ stent during index and/or staged procedure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289002

  Show 69 Study Locations
Sponsors and Collaborators
Biosensors Europe SA
Investigators
Principal Investigator: Philip Urban, MD Hôpital de la Tour
  More Information

No publications provided

Responsible Party: Biosensors Europe SA
ClinicalTrials.gov Identifier: NCT01289002     History of Changes
Other Study ID Numbers: 07EU02
Study First Received: February 2, 2011
Last Updated: January 1, 2013
Health Authority: Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014