NCT01254487

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,121

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

4.5 years

First QC Date

December 3, 2010

Last Update Submit

May 3, 2019

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

"Real world, all comer" patients

You may qualify if:

  • Age ≥18 years
  • Patients that need a treatment with a BioMatrix™ drug-eluting stent
  • 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
  • No limitation on the number of treated lesions, and vessels, and lesion length

You may not qualify if:

  • Inability to provide informed consent
  • Patients needing additional stent NOT of the BioMatrix™ type
  • Patients receiving next to the BioMatrix™ stent also other coronary vascular interventions, for example dilation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Arrixaca University Hospital

Murcia, 30120, Spain

Location

Inselspital

Bern, 3010, Switzerland

Location

Hôpital Cantonal de Fribourg

Fribourg, 1708, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, 1211, Switzerland

Location

Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

Hôpital de La Tour

Meyrin, 1217, Switzerland

Location

Triemli Hospital

Zurich, 8063, Switzerland

Location

Brighton-Sussex University Hospitals

Brighton, BN2 5BE, United Kingdom

Location

Manchester Heart Center

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Philip Urban, MD

    Hôpital de La Tour

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2010

First Posted

December 6, 2010

Study Start

March 1, 2008

Primary Completion

September 1, 2012

Study Completion

September 1, 2014

Last Updated

May 6, 2019

Record last verified: 2019-05

Locations

GB(2)ES(1)CH(6)