e-BioMatrix PostMarket Surveillance Registry

Coronary Artery Disease Clinical Trial

Official title:

A Postmarket Surveillance Registry of the BioMatrix Drug-eluting Stent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254487
• Other study ID #: 07EU01
• Status: Completed
• Start date: March 2008
• Est. completion date: September 2014

Study information

• Verified date: May 2019
• Source: Biosensors Europe SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1121
• Est. completion date: September 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Spain	Arrixaca University Hospital	Murcia
Switzerland	Inselspital	Bern
Switzerland	Hôpital Cantonal de Fribourg	Fribourg
Switzerland	Hôpitaux Universitaires de Genève	Geneva
Switzerland	Cardiocentro Ticino	Lugano
Switzerland	Hôpital de La Tour	Meyrin
Switzerland	Triemli Hospital	Zürich
United Kingdom	Brighton-Sussex University Hospitals	Brighton
United Kingdom	Manchester Heart Center	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Biosensors Europe SA

Countries where clinical trial is conducted

Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 Months
Secondary	Primary and secondary stent thrombosis (definite and probable according to ARC definitions)		30 days, 6 and 12 months, 2, 3 and 5 years
Secondary	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		30 days, 6 months, 2, 3 and 5 years
Secondary	Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any clinically driven target vessel revascularization		30 days, 6 and 12 months, 2, 3 and 5 years
Secondary	Death and MI		30 days, 6 and 12 months, 2, 3 and 5 years
Secondary	Total revascularization rate (clinically and non clinically driven)		30 days, 6 and 12 months, 2, 3 and 5 years