e-BioMatrix PostMarket Surveillance Registry

A Postmarket Surveillance Registry of the BioMatrix Drug-eluting Stent

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01254487

Enrollment

1121

Registered

2010-12-06

Start date

2008-03-31

Completion date

2014-09-30

Last updated

2019-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Primary and secondary stent thrombosis (definite and probable according to ARC definitions)	30 days, 6 and 12 months, 2, 3 and 5 years
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
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
Death and MI	30 days, 6 and 12 months, 2, 3 and 5 years
Total revascularization rate (clinically and non clinically driven)	30 days, 6 and 12 months, 2, 3 and 5 years

Countries

Spain, Switzerland, United Kingdom

Outcome results