Evaluation of Effectiveness and Safety of BIOMATRIX in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Seung-Jung Park20 sites in 1 country837 target enrollmentMay 2010

ConditionsCoronary Artery Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Seung-Jung Park
Enrollment: 837
Locations: 20
Primary Endpoint: composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate effectiveness and safety of BioMatrix stent in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus- or paclitaxel-eluting stents).

Detailed Description

This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of BioMatrix stents versus first-generation drug-eluting stent (DES) in patients with coronary artery disease.

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

August 14, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Seung-Jung Park

Responsible Party

Sponsor Investigator

Principal Investigator

Seung-Jung Park

MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

CardioVascular Research Foundation, Korea

Eligibility Criteria

Inclusion Criteria

•Patients receiving BioMatrix stents
•The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria

•Patients with a mixture of other DESs
•Terminal illness with life expectancy \<1 year
•Patients with cardiogenic shock

Outcomes

Primary Outcomes

composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)

Time Frame: 12 months post procedure

Secondary Outcomes

Target-lesion revascularization (TLR)(yearly upto 5 years)
Cardiac death(yearly upto 5 years)
TVR(yearly upto 5 years)
All Death(yearly upto 5 years)
MI(yearly upto 5 years)
Composite of death or MI(yearly upto 5 years)
Composite of cardiac death or MI(yearly upto 5 years)
Stent thrombosis (ARC criteria)(yearly upto 5 years)
Procedural success defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization(3 days in average)