Clinical trial NCT01350778: Evaluation of Effectiveness and Safety of BIOMATRIX Stent (IRIS-BIOMATRIX)
Official title: Evaluation of Effectiveness and Safety of BIOMATRIX in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease requiring drug eluting stents
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
name: Dio
First posted: 2011-05-10
Enrollment: 837
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving BioMatrix 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.

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

Primary outcomes:
measure: composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
timeFrame: 12 months post procedure
Secondary outcomes:
measure: All Death
timeFrame: one month
measure: All Death
timeFrame: 6 months
measure: All Death
timeFrame: yearly upto 5 years
measure: Cardiac death
timeFrame: one month
measure: Cardiac death
timeFrame: 6 months
measure: Cardiac death
timeFrame: yearly upto 5 years
measure: MI
timeFrame: one month
measure: MI
timeFrame: 6 months
measure: MI
timeFrame: yearly upto 5 years
measure: Composite of death or MI
timeFrame: one month
measure: Composite of death or MI
timeFrame: 6 months
measure: Composite of death or MI
timeFrame: yearly upto 5 years
measure: Composite of cardiac death or MI
timeFrame: one month
measure: Composite of cardiac death or MI
timeFrame: 6 months
measure: Composite of cardiac death or MI
timeFrame: yearly upto 5 years
measure: TVR
timeFrame: one month
measure: TVR
timeFrame: 6 months
measure: TVR
timeFrame: yearly upto 5 years
measure: Target-lesion revascularization (TLR)
timeFrame: one month
measure: Target-lesion revascularization (TLR)
timeFrame: 6 months
measure: Target-lesion revascularization (TLR)
timeFrame: yearly upto 5 years
measure: Stent thrombosis (ARC criteria)
timeFrame: one month
measure: Stent thrombosis (ARC criteria)
timeFrame: 6 months
measure: Stent thrombosis (ARC criteria)
timeFrame: yearly upto 5 years
measure: 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
timeFrame: 3 days in average
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST. Mary's Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: National Health Insurance Corporation Ilsan Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Kwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A Medical Center
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Eulji general hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea St. Paul's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St.Mary's Hospital
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea Uijeongbu St. Mary's Hospital
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul St. Mary's Hospital, Catholic University of Korea
name: Ki Bae Seung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: