e-BioMatrix PostMarket Surveillance Registry

NCT ID: NCT01254487

Last Updated: 2019-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biosensors Europe SA

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philip Urban, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital de La Tour

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arrixaca University Hospital

Murcia, , Spain

Site Status

Inselspital

Bern, , Switzerland

Site Status

Hôpital Cantonal de Fribourg

Fribourg, , Switzerland

Site Status

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Site Status

Cardiocentro Ticino

Lugano, , Switzerland

Site Status

Hôpital de La Tour

Meyrin, , Switzerland

Site Status

Triemli Hospital

Zurich, , Switzerland

Site Status

Brighton-Sussex University Hospitals

Brighton, , United Kingdom

Site Status

Manchester Heart Center

Manchester, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain Switzerland United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

07EU01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

BioFreedom™ BA9™ Ultra
NCT05331547 UNKNOWN
LEADERS FREE II: BioFreedom™ Pivotal Study
NCT02843633 ACTIVE_NOT_RECRUITING NA
BioFreedom US IDE Feasibility Trial
NCT02131142 UNKNOWN PHASE2/PHASE3