Evaluation of Effectiveness and Safety of BIOMATRIX Stent (IRIS-BIOMATRIX)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01350778

Enrollment

837

Registered

2011-05-10

Start date

2010-05-31

Completion date

2020-08-14

Last updated

2021-01-27

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

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease requiring drug eluting stents

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)	12 months post procedure

Secondary

Measure	Time frame	Description
Cardiac death	one month	—
MI	one month	—
Composite of death or MI	one month	—
Composite of cardiac death or MI	one month	—
All Death	one month	—
Target-lesion revascularization (TLR)	one month	—
Stent thrombosis (ARC criteria)	one month	—
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	At discharge from the index hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days.
TVR	one month	—

Countries

South Korea

Outcome results