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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350778
• Other study ID #: CVRF2010-03
• Status: Completed
• Start date: May 2010
• Est. completion date: August 14, 2020

Study information

• Verified date: January 2021
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 837
• Est. completion date: August 14, 2020
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea, Dio

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)		12 months post procedure
Secondary	All Death		one month
Secondary	All Death		6 months
Secondary	All Death		yearly upto 5 years
Secondary	Cardiac death		one month
Secondary	Cardiac death		6 months
Secondary	Cardiac death		yearly upto 5 years
Secondary	MI		one month
Secondary	MI		6 months
Secondary	MI		yearly upto 5 years
Secondary	Composite of death or MI		one month
Secondary	Composite of death or MI		6 months
Secondary	Composite of death or MI		yearly upto 5 years
Secondary	Composite of cardiac death or MI		one month
Secondary	Composite of cardiac death or MI		6 months
Secondary	Composite of cardiac death or MI		yearly upto 5 years
Secondary	TVR		one month
Secondary	TVR		6 months
Secondary	TVR		yearly upto 5 years
Secondary	Target-lesion revascularization (TLR)		one month
Secondary	Target-lesion revascularization (TLR)		6 months
Secondary	Target-lesion revascularization (TLR)		yearly upto 5 years
Secondary	Stent thrombosis (ARC criteria)		one month
Secondary	Stent thrombosis (ARC criteria)		6 months
Secondary	Stent thrombosis (ARC criteria)		yearly upto 5 years
Secondary	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