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

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

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.

• Study Type: Observational
• Enrollment (Actual): 837

Contacts and Locations

Study Locations

• Korea, Republic of
  • Cheonan, Korea, Republic of
    • Soon Chun Hyang University Hospital Cheonan
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of
    • The Catholic University of Korea, Daejeon ST. Mary's Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Ilsan, Korea, Republic of
    • National Health Insurance Corporation Ilsan Hospital
  • Incheon, Korea, Republic of
    • Inha University Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Hospital
  • Jinju, Korea, Republic of
    • Gyeongsang National University Hospital
  • Kwangju, Korea, Republic of
    • Kwangju Christian Hospital
  • Pusan, Korea, Republic of
    • Inje University Pusan Paik Hospital
  • Pusan, Korea, Republic of
    • Dong-A Medical Center
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Eulji General Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea St. Paul's Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Seoul St.Mary's Hospital
  • Uijeongbu, Korea, Republic of
    • The Catholic University of Korea Uijeongbu St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving BioMatrix stents

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Biomatrix stent; patients treated with Biomatrix stent

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of death or MI		6 months
Composite of cardiac death or MI		6 months
Composite of death or MI		one month
Composite of cardiac death or MI		one month
All Death		one month
All Death		6 months
All Death		yearly upto 5 years
Cardiac death		one month
Cardiac death		6 months
Cardiac death		yearly upto 5 years
MI		one month
MI		6 months
MI		yearly upto 5 years
Composite of death or MI		yearly upto 5 years
Composite of cardiac death or MI		yearly upto 5 years
TVR		one month
TVR		6 months
TVR		yearly upto 5 years
Target-lesion revascularization (TLR)		one month
Target-lesion revascularization (TLR)		6 months
Target-lesion revascularization (TLR)		yearly upto 5 years
Stent thrombosis (ARC criteria)		one month
Stent thrombosis (ARC criteria)		6 months
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	At discharge from the index hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days.	3 days in average

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: Dio; CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): August 14, 2020

Study Registration Dates

• First Submitted: May 4, 2011
• First Submitted That Met QC Criteria: May 9, 2011
• First Posted (Estimate): May 10, 2011

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Coronary artery disease requiring drug eluting stents
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CVRF2010-03