Coronary Artery DiseasePhase 4KOTRINCT01803841
Korea Transradial Coronary Intervention Prospective Registry (KOTRI)
A Phase 4 study testing Transradial coronary angiography and intervention and Transfemoral coronary angiography and intervention in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
The aim of this registry is to analyze several factors affecting the procedural success and clinical outcomes at 1 year of follow-up according to the approach site. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Transradial coronary angiography and intervention and Transfemoral coronary angiography and intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Jun 2015
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consecutive hospitalized patients undergoing coronary angiography or percutaneous coronary intervention
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 220-701
About this study
The aim of this registry is to analyze several factors affecting the procedural success and clinical outcomes at 1 year of follow-up according to the approach site.
Read the detailed description
This registry is a multi-center prospective registry for patients undergoing coronary angiography or percutaneous coronary intervention either transradial or transfemoral approach from 22 centers in South Korea. The aim of this registry is to analyze several factors affecting the procedural success and clinical outcomes at 1 year of follow-up according to the approach site.
- Conditions
- Coronary Artery Disease
- Being tested
- Transradial coronary angiography and intervention, Transfemoral coronary angiography and intervention
- Keywords
- Coronary artery disease
- 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.
Transradial coronary angiography and interventionProcedure or surgery
Transfemoral coronary angiography and interventionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Transradial access | Active comparator | Coronary angiography and intervention via radial artery approach Receives: Procedure: Transradial coronary angiography and intervention |
| Transfemoral access | Active comparator | Coronary angiography and intervention via femoral artery approach Receives: Procedure: Transfemoral coronary angiography and intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-oriented composite outcome
The composite of any death, non-fatal myocardial infarction, and any revascularization
Measured: 1 year
Secondary outcomes (4)
Access failure
Conversion rate of access site
Measured: Day 0 (end of procedure)
Success of percutaneous coronary intervention
Combination of angiographic success and procedural success
- Angiographic success; thrombolysis in myocardial infarction (TIMI) flow grad 3 and <30% residual diameter stenosis
- Procedural success; Angiographic success without major procedural or in-hospital complications such as death, Q-wave myocardial infarction, or emergency bypass surgery
Measured: Day 3 (day of discharge)
Procedure time
Procedure time according to the access site
Measured: Day 0 (end of procedure)
Fluoroscopic time
Fluoroscopic time according to the access site
Measured: Day 0 (end of procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- The Korean Society of Cardiology
- Responsible party
- Principal investigator, Yoon Junghan, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803841
- Sponsor's protocol ID
- KOTRI
- Acronym
- KOTRI
- Status last verified
- Nov 2016
- First submitted
- 25 Feb 2013
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Choe JC, Cha KS, Choi JH, Kim BW, Park JS, Lee HW, Oh JH, Choi JH, Lee HC, Hong TJ, Youn YJ, Lee SH, Cho BR, Kim DI, Han KR, Jeong MH, Yoon J; Korea Transradial Coronary Intervention (KOTRI) Prospective Registry Investigators. Comparison of Frequency of Bleeding and Major Adverse Cardiac Events After Transradial Versus Transfemoral Intervention in the Recent Antiplatelet Era. Am J Cardiol. 2016 May 15;117(10):1588-1595. doi: 10.1016/j.amjcard.2016.02.033. Epub 2016 Mar 2.
PubMed 27026640Lee SH, Jeong MH, Han KR, Sim DS, Yoon J, Youn YJ, Cho BR, Cha KS, Hyon MS, Rha SW, Kim BO, Shin WY, Park KS, Cheong SS; Korean Transradial Coronary Intervention Registry Investigators. Comparison of Transradial and Transfemoral Approaches for Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome and Anemia. Am J Cardiol. 2016 May 15;117(10):1582-1587. doi: 10.1016/j.amjcard.2016.02.030. Epub 2016 Mar 2.
PubMed 27018932Youn YJ, Lee JW, Ahn SG, Lee SH, Yoon J, Cho BR, Cheong SS, Kim HY, Lee JH, Bae JH, Lee JB, Suh J, Park KS, Han KR, Jeong MH, Rha SW, Her SH, Cho YH, Kim SW. Current Practice of Transradial Coronary Angiography and Intervention: Results from the Korean Transradial Intervention Prospective Registry. Korean Circ J. 2015 Nov;45(6):457-68. doi: 10.4070/kcj.2015.45.6.457. Epub 2015 Nov 25.
PubMed 26617647
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korea Transradial Coronary Intervention Prospective Registry (KOTRI)
- ClinicalTrials.gov ID
- NCT01803841
- Acronym / sponsor ID
- KOTRI / KOTRI
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,300 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- The Korean Society of Cardiology
- Study start
- Feb 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Mar 2013 (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.
The aim of this registry is to analyze several factors affecting the procedural success and clinical outcomes at 1 year of follow-up according to the approach site.
Detailed description
This registry is a multi-center prospective registry for patients undergoing coronary angiography or percutaneous coronary intervention either transradial or transfemoral approach from 22 centers in South Korea. The aim of this registry is to analyze several factors affecting the procedural success and clinical outcomes at 1 year of follow-up according to the approach site.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transradial access | Active comparator | Procedure: Transradial coronary angiography and interventionCoronary angiography and intervention via radial artery approach |
| Transfemoral access | Active comparator | Procedure: Transfemoral coronary angiography and interventionCoronary angiography and intervention via femoral artery approach |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive hospitalized patients undergoing coronary angiography or percutaneous coronary intervention
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transradial coronary angiography and intervention | Procedure or surgery | Transradial access |
| Transfemoral coronary angiography and intervention | Procedure or surgery | Transfemoral access |
Primary outcome
Patient-oriented composite outcome
Time frame: 1 year
The composite of any death, non-fatal myocardial infarction, and any revascularization
4 secondary outcomes
Access failure
Time frame: Day 0 (end of procedure)
Success of percutaneous coronary intervention
Time frame: Day 3 (day of discharge)
Procedure time
Time frame: Day 0 (end of procedure)
Fluoroscopic time
Time frame: Day 0 (end of procedure)
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 15 Nov 2016.
- Background: PubMed 27026640Choe JC, Cha KS, Choi JH, Kim BW, Park JS, Lee HW, Oh JH, Choi JH, Lee HC, Hong TJ, Youn YJ, Lee SH, Cho BR, Kim DI, Han KR, Jeong MH, Yoon J; Korea Transradial Coronary Intervention (KOTRI) Prospective Registry Investigators. Comparison of Frequency of Bleeding and Major Adverse Cardiac Events After Transradial Versus Transfemoral Intervention in the Recent Antiplatelet Era. Am J Cardiol. 2016 May 15;117(10):1588-1595. doi: 10.1016/j.amjcard.2016.02.033. Epub 2016 Mar 2.
- Background: PubMed 27018932Lee SH, Jeong MH, Han KR, Sim DS, Yoon J, Youn YJ, Cho BR, Cha KS, Hyon MS, Rha SW, Kim BO, Shin WY, Park KS, Cheong SS; Korean Transradial Coronary Intervention Registry Investigators. Comparison of Transradial and Transfemoral Approaches for Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome and Anemia. Am J Cardiol. 2016 May 15;117(10):1582-1587. doi: 10.1016/j.amjcard.2016.02.030. Epub 2016 Mar 2.
- Results publication: PubMed 26617647Youn YJ, Lee JW, Ahn SG, Lee SH, Yoon J, Cho BR, Cheong SS, Kim HY, Lee JH, Bae JH, Lee JB, Suh J, Park KS, Han KR, Jeong MH, Rha SW, Her SH, Cho YH, Kim SW. Current Practice of Transradial Coronary Angiography and Intervention: Results from the Korean Transradial Intervention Prospective Registry. Korean Circ J. 2015 Nov;45(6):457-68. doi: 10.4070/kcj.2015.45.6.457. Epub 2015 Nov 25.
- TRI retrospective registry electronic case report form (eCRF)Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transradial coronary angiography and intervention and Transfemoral coronary angiography and intervention in people with Coronary Artery Disease, run by Yonsei University at 1 site 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 1 inclusion and 1 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 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Patient-oriented composite outcome (time frame: 1 year). 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 NCT01803841, which also lists 3 linked publications.
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 15 Nov 2016.