Clinical trial NCT01254487: e-BioMatrix PostMarket Surveillance Registry
Official title: A Postmarket Surveillance Registry of the BioMatrix Drug-eluting Stent
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 1121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: "Real world, all comer" patients

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 12 Months
Secondary outcomes:
measure: Primary and secondary stent thrombosis (definite and probable according to ARC definitions)
timeFrame: 30 days, 6 and 12 months, 2, 3 and 5 years
measure: 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
timeFrame: 30 days, 6 months, 2, 3 and 5 years
measure: Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any clinically driven target vessel revascularization
timeFrame: 30 days, 6 and 12 months, 2, 3 and 5 years
measure: Death and MI
timeFrame: 30 days, 6 and 12 months, 2, 3 and 5 years
measure: Total revascularization rate (clinically and non clinically driven)
timeFrame: 30 days, 6 and 12 months, 2, 3 and 5 years
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Arrixaca University Hospital
city: Bern
country: Switzerland
facility: Inselspital
city: Fribourg
country: Switzerland
facility: Hôpital Cantonal de Fribourg
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
city: Meyrin
country: Switzerland
facility: Hôpital de La Tour
city: Zürich
country: Switzerland
facility: Triemli Hospital
city: Brighton
country: United Kingdom
facility: Brighton-Sussex University Hospitals
city: Manchester
country: United Kingdom
facility: Manchester Heart Center
Study officials:
affiliation: Hôpital de La Tour
name: Philip Urban, MD
role: PRINCIPAL_INVESTIGATOR
References: