Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

e-BioMatrix PostMarket Surveillance Registry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biosensors Europe SA
ClinicalTrials.gov Identifier:
NCT01254487
First received: December 3, 2010
Last updated: September 6, 2014
Last verified: September 2014
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Postmarket Surveillance Registry of the BioMatrix Drug-eluting Stent

Further study details as provided by Biosensors Europe SA:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ 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 [ Time Frame: 30 days, 6 months, 2, 3 and 5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Death and MI [ 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) [ Time Frame: 30 days, 6 and 12 months, 2, 3 and 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 1121
Study Start Date: March 2008
Estimated Study Completion Date: April 2015
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  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 a BioMatrix™ 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 BioMatrix™ type
  3. Patients receiving next to the BioMatrix™ stent also other coronary vascular interventions, for example dilation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01254487

Locations
Spain
Arrixaca University Hospital
Murcia, Spain, 30120
Switzerland
Inselspital
Bern, Switzerland, 3010
Hôpital Cantonal de Fribourg
Fribourg, Switzerland, 1708
Hôpitaux Universitaires de Genève
Geneva, Switzerland, 1211
Cardiocentro Ticino
Lugano, Switzerland, 6900
Hôpital de La Tour
Meyrin, Switzerland, 1217
Triemli Hospital
Zürich, Switzerland, 8063
United Kingdom
Brighton-Sussex University Hospitals
Brighton, United Kingdom, BN2 5BE
Manchester Heart Center
Manchester, United Kingdom, M13 9WL
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: NCT01254487     History of Changes
Other Study ID Numbers: 07EU01
Study First Received: December 3, 2010
Last Updated: September 6, 2014
Health Authority: Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on November 24, 2014