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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: September 6, 2014
Last verified: September 2014

February 2, 2011
September 6, 2014
April 2008
September 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01289002 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
e-BioMatrix PostMarket Registry
A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

"Real world, all comer" patients

Coronary Artery Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4000
April 2015
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Czech Republic,   Denmark,   France,   Germany,   Ireland,   Jordan,   Latvia,   Lithuania,   Morocco,   Poland,   Portugal,   Russian Federation,   Spain,   Switzerland,   United Kingdom
 
NCT01289002
07EU02
Yes
Biosensors Europe SA
Biosensors Europe SA
Not Provided
Principal Investigator: Philip Urban, MD Hôpital de la Tour
Biosensors Europe SA
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP