e-BioMatrix PostMarket Registry

A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01289002

Acronym

eBMX-PMR

Enrollment

5652

Registered

2011-02-03

Start date

2008-04-30

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 this registry is to capture clinical data of the BioMatrix™ and BioMatrix Flex™ (Biolimus A9™-Eluting) stent systems in relation to safety and effectiveness.

Detailed description

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

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 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

Design outcomes

Primary

Measure	Time frame	Description
MACE	12 months	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.

Secondary

Measure	Time frame	Description
MACE	30 days, 6 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 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;	6 and 12 months, 2, 3 and 5 years	—
stent thrombosis	30 days, 6 and 12 months, 2, 3 and 5 years	Primary and secondary stent thrombosis (definite and probable according to ARC definitions) at 30 days, 6 and 12 months, 2, 3 and 5 years;
Death and post-procedural MI at 30 days, 6 and 12 months, 2, 3 and 5 years;	30 days, 6 and 12 months, 2, 3 and 5 years	—
Total revascularization rate (clinically and non clinically driven) at 30 days, 6 and 12 months, 2, 3 and 5 years.	30 days, 6 and 12 months, 2, 3 and 5 years.	—
Death and MI at 30 days, 6 and 12 months, 2, 3 and 5 years;	30 days, 6 and 12 months, 2, 3 and 5 years;	—

Countries

Austria, Czechia, Denmark, France, Germany, Ireland, Jordan, Latvia, Lithuania, Morocco, Poland, Portugal, Russia, Spain, Switzerland, United Kingdom

Outcome results