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

An observational study of Coronary Artery Disease, run by Seung-Jung Park at 20 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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). Read more about this study

Who is it for?: Any age
Conditions the study is for: Coronary Artery Disease
How many people: 837 participants
Where: 20 sitesSouth Korea
Study dates: May 2010to 14 Aug 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients receiving BioMatrix stents

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

South Korea20 sites

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

Other trials in South Korea

About this study

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

Read the 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.

Conditions: Coronary Artery Disease
Keywords: Coronary artery disease requiring drug eluting stents
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01350778
Study group	Role	What they receive
Biomatrix stent		patients treated with Biomatrix stent

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (25)

All Death
Measured: one month
All Death
Measured: 6 months
All Death
Measured: yearly upto 5 years
Cardiac death
Measured: one month
Cardiac death
Measured: 6 months
Cardiac death
Measured: yearly upto 5 years
MI
Measured: one month
MI
Measured: 6 months
MI
Measured: yearly upto 5 years
Composite of death or MI
Measured: one month
Composite of death or MI
Measured: 6 months
Composite of death or MI
Measured: yearly upto 5 years
Composite of cardiac death or MI
Measured: one month
Composite of cardiac death or MI
Measured: 6 months
Composite of cardiac death or MI
Measured: yearly upto 5 years
TVR
Measured: one month
TVR
Measured: 6 months
TVR
Measured: yearly upto 5 years
Target-lesion revascularization (TLR)
Measured: one month
Target-lesion revascularization (TLR)
Measured: 6 months
Target-lesion revascularization (TLR)
Measured: yearly upto 5 years
Stent thrombosis (ARC criteria)
Measured: one month
Stent thrombosis (ARC criteria)
Measured: 6 months
Stent thrombosis (ARC criteria)
Measured: 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.
Measured: 3 days in average

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201014 Aug 2020

First posted10 May 2011 (estimated)
Study startMay 2010
Primary completion1 Jul 2016
Study completion14 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 837 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01350778
Sponsor's protocol ID: CVRF2010-03
Status last verified: Jan 2021
First submitted: 4 May 2011
Last updated: 27 Jan 2021
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Effectiveness and Safety of BIOMATRIX in Routine Clinical Practice; A Multicenter, Prospective Observational Study
ClinicalTrials.gov ID: NCT01350778
Acronym / sponsor ID: CVRF2010-03
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease requiring drug eluting stents
Study type: Observational
Recruitment status: Completed
Enrolment: 837 participants (actual)
Lead sponsor: Seung-Jung ParkUniversity, hospital or other
Collaborators: CardioVascular Research Foundation, Korea, Dio
Study start: May 2010
Primary completion: 1 Jul 2016 (actual)
Study completion: 14 Aug 2020 (actual)
First posted: 10 May 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Biomatrix stent	–	–patients treated with Biomatrix stent

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients receiving BioMatrix stents

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

25 secondary outcomes

All Death
Time frame: one month
All Death
Time frame: 6 months
All Death
Time frame: yearly upto 5 years
Cardiac death
Time frame: one month
Cardiac death
Time frame: 6 months
Cardiac death
Time frame: yearly upto 5 years
MI
Time frame: one month
MI
Time frame: 6 months
MI
Time frame: yearly upto 5 years
Composite of death or MI
Time frame: one month
Composite of death or MI
Time frame: 6 months
Composite of death or MI
Time frame: yearly upto 5 years
Composite of cardiac death or MI
Time frame: one month
Composite of cardiac death or MI
Time frame: 6 months
Composite of cardiac death or MI
Time frame: yearly upto 5 years
TVR
Time frame: one month
TVR
Time frame: 6 months
TVR
Time frame: yearly upto 5 years
Target-lesion revascularization (TLR)
Time frame: one month
Target-lesion revascularization (TLR)
Time frame: 6 months
Target-lesion revascularization (TLR)
Time frame: yearly upto 5 years
Stent thrombosis (ARC criteria)
Time frame: one month
Stent thrombosis (ARC criteria)
Time frame: 6 months
Stent thrombosis (ARC criteria)
Time frame: 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
Time frame: 3 days in average

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.

Related trials for Coronary Artery Disease

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Seung-Jung Park, MD, PhD principal investigator

Asan Medical Center

Ki Bae Seung, MD, PhD principal investigator

Seoul St. Mary's Hospital, Catholic University of Korea

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Seung-Jung Park at 20 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) (time frame: 12 months post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01350778.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.