Coronary Artery DiseaseGWPCINCT02038127
Gangwon PCI Prospective Registry
An observational study of Coronary Artery Disease and Ischemic Heart Disease (IHD), run by Yonsei University at 4 sites in South Korea.
Trial summary
This prospective, multicenter registry will consecutively enroll patients of all ages undergoing percutaneous coronary intervention (PCI) at four university hospitals in Gangwon Province, Republic of Korea. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Ischemic Heart Disease (IHD), Unstable Angina (UA)
- What is being tested?
- Percutaneous Coronary Intervention (PCI)
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 1 Jan 2013to 31 Dec 2031
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population will consist of consecutive, all-comer patients of any age undergoing percutaneous coronary intervention (PCI) at four participating university hospitals in Gangwon Province, Republic of Korea. Patients undergoing PCI for any clinical presentation, including chronic coronary syndrome and acute coronary syndrome, will be eligible. There will be no restrictions based on sex, clinical presentation, comorbidity, lesion complexity, or procedural characteristics. Patients undergoing staged PCI during the same hospitalization will be included. Information on the initial and subsequent procedures will be recorded separately using dedicated electronic case report forms.
Who may be able to join
- Patients of any age undergoing percutaneous coronary intervention (PCI) at a participating hospital during the study period.
- Written informed consent is obtained from the patient or a legally authorized representative before collection of study data, unless the requirement for informed consent is waived by the Institutional Review Board.
Who cannot join
- Refusal or withdrawal of informed consent, when informed consent is required.
- No PCI performed during the index hospital encounter.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Recruiting
Chuncheon Hallym University Hospital
Chuncheon, Gangwon-do, 24253
Hyun Hee Choi, M.D., 82-33-240-5000, jumdure@hanmail.net
Hyun Hee Choi, M.D.
- Recruiting
Kangwon National University Hospital
Chuncheon, Gangwon-do, 24289
Bong-Ki Lee, M.D., Ph.D., 82-33-258-2000, mdbklee@kangwon.ac.kr
Cheol Ung Choi, M.D., Ph.D.
- Recruiting
Gangneung Asan Hospital
Gangneung, Gangwon-do, 25440
Hanbit Park, M.D., Ph.D., 82-33-610-3114, phb8012@gmail.com
- Recruiting
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Young Jin Youn, M.D., Ph.D., +82-33-741-0917, younyj@yonsei.ac.kr
Young Jin Youn, M.D., Ph.D.
About this study
Official title: Prospective Registry for Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention in Gangwon Province
This prospective, multicenter registry will consecutively enroll patients of all ages undergoing percutaneous coronary intervention (PCI) at four university hospitals in Gangwon Province, Republic of Korea.
The study will describe contemporary clinical, procedural, and medication treatment patterns and assess 1-year clinical outcomes in routine practice.
The primary outcome is patient-oriented composite outcome (POCO), defined as all-cause death, any myocardial infarction, or any repeat revascularization.
No study-specific intervention will be assigned.
Read the detailed description
This prospective, multicenter, observational registry will consecutively enroll patients of all ages undergoing percutaneous coronary intervention (PCI) at four university hospitals in Gangwon Province, Republic of Korea.
The registry is designed to provide real-world data on the clinical characteristics, angiographic findings, procedural strategies, and pharmacological treatment patterns of patients treated with PCI.
PCI and all subsequent medical care will be performed according to routine clinical practice and at the discretion of the treating physicians. The study will not mandate any diagnostic test, procedural strategy, device, or medication.
Baseline clinical characteristics, cardiovascular risk factors, laboratory findings, angiographic and lesion characteristics, procedural details, in-hospital events, discharge medications, and follow-up clinical outcomes will be prospectively recorded.
For patients undergoing staged PCI during the same hospitalization, information on the initial and subsequent procedures will be recorded separately using dedicated electronic case report forms.
Clinical outcomes will be assessed for 1 year after PCI through review of medical records, outpatient follow-up, and telephone contact.
The primary outcome is patient-oriented composite outcome (POCO), defined as all-cause death, any myocardial infarction, or any repeat revascularization. The registry will evaluate the incidence of POCO and examine its associations with baseline clinical, angiographic, procedural, and treatment-related characteristics.
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease (IHD), Unstable Angina (UA), Non-ST Elevated Myocardial Infarction, ST-Elevation Myocardial Infarction, Vasospastic Angina
- Being tested
- Percutaneous Coronary Intervention (PCI)
- Keywords
- Percutaneous Coronary Intervention (PCI), Coronary Artery Disease, Prospective Multicenter Registry, Clinical Outcomes
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Angina, Unstable, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction, Angina Pectoris, Variant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention (PCI)Procedure or surgery
PCI performed as part of routine clinical care; no study-specific procedure is assigned.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing PCI | All consecutively enrolled patients undergoing percutaneous coronary intervention at the participating hospitals. PCI is performed as part of routine clinical care and is not assigned by the study protocol. Receives: Procedure: Percutaneous Coronary Intervention (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-oriented composite outcome (POCO)
A composite of all-cause death, any myocardial infarction, or any repeat revascularization.
Measured: Within 1 year after the index PCI procedure
Secondary outcomes (10)
Device-oriented composite outcome (DOCO)
A composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization.
Measured: Within 1 year after the index PCI procedure
All-cause death
Death from any cause
Measured: Within 1 year after the index PCI procedure
Cardiovascular death
Death resulting from a cardiovascular cause.
Measured: Within 1 year after the index PCI procedure
Any myocardial infarction
Any myocardial infarction occurring after the index PCI procedure.
Measured: Within 1 year after the index PCI procedure
Target-vessel myocardial infarction
Myocardial infarction attributable to the coronary vessel treated during the index PCI procedure.
Measured: Within 1 year after the index PCI procedure
Clinically indicated Target vessel revascularization (TVR)
Repeat percutaneous coronary intervention or coronary artery bypass grafting of any segment of the target vessel, including the target lesion, when clinically indicated.
Measured: Within 1 year after the index PCI procedure
Clinically indicated Target vessel revascularization (TVR)
Repeat percutaneous coronary intervention of the target lesion or coronary artery bypass grafting of the target vessel for restenosis or another complication of the target lesion, when clinically indicated. The target lesion includes the treated segment and the 5-mm margins proximal and distal to the implanted stent.
Measured: Within 1 year after the index PCI procedure
Any repeat revascularization
Any repeat coronary revascularization, including repeat PCI or coronary artery bypass grafting.
Measured: Within 1 year after the index PCI procedure
Definite or probable stent thrombosis
Definite or probable stent thrombosis according to the Academic Research Consortium criteria.
Measured: Within 1 year after the index PCI procedure
Major bleeding
Major bleeding defined as Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding.
Measured: Within 1 year after the index PCI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study start1 Jan 2013
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Gangwon Cardiovascular Health Research Institute
- Responsible party
- Principal investigator, Young Jin Youn, MD, PhD, Yonsei University
- Investigators
- Young Jin Youn, M.D., Ph.D., Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038127
- Sponsor's protocol ID
- GangwonPCI
- Acronym
- GWPCI
- Status last verified
- Oct 2026
- First submitted
- 14 Jan 2014
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the multicenter registry contains potentially identifiable clinical data, and no data-sharing governance framework has been established among the participating institutions.
Publications
Jeon HS, Youn YJ, Lee JH, Park YJ, Son JW, Lee JW, Ahn MS, Ahn SG, Kim JY, Yoo BS, Yoon J. Safety and Efficacy of Two Ultrathin Biodegradable Polymer Sirolimus-Eluting Stents in Real-World Practice: Genoss DES Stents Versus Orsiro Stents From a Prospective Registry. Clin Cardiol. 2024 Dec;47(12):e70060. doi: 10.1002/clc.70060.
PubMed 39691038Jeon HS, Kim YI, Lee JH, Park YJ, Son JW, Lee JW, Youn YJ, Ahn MS, Kim JY, Yoo BS, Ko SM, Ahn SG. Failed Thrombus Aspiration and Reduced Myocardial Perfusion in Patients With STEMI and Large Thrombus Burden. JACC Cardiovasc Interv. 2024 Oct 14;17(19):2216-2225. doi: 10.1016/j.jcin.2024.07.016. Epub 2024 Sep 18.
PubMed 39297854Youn YJ, Jeon HS, Kim YI, Lee JH, Park YJ, Cho DH, Son JW, Lee JW, Ahn MS, Ahn SG, Kim JY, Yoo BS, Lee SH, Yoon J. Impact of the ultra-long 48 mm drug-eluting stent on procedural and clinical outcomes in patients with diffuse long coronary artery disease. Clin Cardiol. 2023 Apr;46(4):416-424. doi: 10.1002/clc.23997. Epub 2023 Feb 20.
PubMed 36807273
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry for Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention in Gangwon Province
- ClinicalTrials.gov ID
- NCT02038127
- Acronym / sponsor ID
- GWPCI / GangwonPCI
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease (IHD), Unstable Angina (UA), Non-ST Elevated Myocardial Infarction, ST-Elevation Myocardial Infarction, Vasospastic Angina
- Keywords
- Percutaneous Coronary Intervention (PCI), Coronary Artery Disease, Prospective Multicenter Registry, Clinical Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Gangwon Cardiovascular Health Research Institute
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 16 Jan 2014 (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.
This prospective, multicenter registry will consecutively enroll patients of all ages undergoing percutaneous coronary intervention (PCI) at four university hospitals in Gangwon Province, Republic of Korea.
The study will describe contemporary clinical, procedural, and medication treatment patterns and assess 1-year clinical outcomes in routine practice.
The primary outcome is patient-oriented composite outcome (POCO), defined as all-cause death, any myocardial infarction, or any repeat revascularization.
No study-specific intervention will be assigned.
Detailed description
This prospective, multicenter, observational registry will consecutively enroll patients of all ages undergoing percutaneous coronary intervention (PCI) at four university hospitals in Gangwon Province, Republic of Korea.
The registry is designed to provide real-world data on the clinical characteristics, angiographic findings, procedural strategies, and pharmacological treatment patterns of patients treated with PCI.
PCI and all subsequent medical care will be performed according to routine clinical practice and at the discretion of the treating physicians. The study will not mandate any diagnostic test, procedural strategy, device, or medication.
Baseline clinical characteristics, cardiovascular risk factors, laboratory findings, angiographic and lesion characteristics, procedural details, in-hospital events, discharge medications, and follow-up clinical outcomes will be prospectively recorded.
For patients undergoing staged PCI during the same hospitalization, information on the initial and subsequent procedures will be recorded separately using dedicated electronic case report forms.
Clinical outcomes will be assessed for 1 year after PCI through review of medical records, outpatient follow-up, and telephone contact.
The primary outcome is patient-oriented composite outcome (POCO), defined as all-cause death, any myocardial infarction, or any repeat revascularization. The registry will evaluate the incidence of POCO and examine its associations with baseline clinical, angiographic, procedural, and treatment-related characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing PCI | – | Procedure: Percutaneous Coronary Intervention (PCI)All consecutively enrolled patients undergoing percutaneous coronary intervention at the participating hospitals. PCI is performed as part of routine clinical care and is not assigned by the study protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of consecutive, all-comer patients of any age undergoing percutaneous coronary intervention (PCI) at four participating university hospitals in Gangwon Province, Republic of Korea. Patients undergoing PCI for any clinical presentation, including chronic coronary syndrome and acute coronary syndrome, will be eligible. There will be no restrictions based on sex, clinical presentation, comorbidity, lesion complexity, or procedural characteristics. Patients undergoing staged PCI during the same hospitalization will be included. Information on the initial and subsequent procedures will be recorded separately using dedicated electronic case report forms.
Key inclusion criteria (2 listed)
- Patients of any age undergoing percutaneous coronary intervention (PCI) at a participating hospital during the study period.
- Written informed consent is obtained from the patient or a legally authorized representative before collection of study data, unless the requirement for informed consent is waived by the Institutional Review Board.
Key exclusion criteria (2 listed)
- Refusal or withdrawal of informed consent, when informed consent is required.
- No PCI performed during the index hospital encounter.
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 |
|---|---|---|
| Percutaneous Coronary Intervention (PCI)PCI performed as part of routine clinical care; no study-specific procedure is assigned. | Procedure or surgery | Patients undergoing PCI |
Primary outcome
Patient-oriented composite outcome (POCO)
Time frame: Within 1 year after the index PCI procedure
A composite of all-cause death, any myocardial infarction, or any repeat revascularization.
10 secondary outcomes
Device-oriented composite outcome (DOCO)
Time frame: Within 1 year after the index PCI procedure
All-cause death
Time frame: Within 1 year after the index PCI procedure
Cardiovascular death
Time frame: Within 1 year after the index PCI procedure
Any myocardial infarction
Time frame: Within 1 year after the index PCI procedure
Target-vessel myocardial infarction
Time frame: Within 1 year after the index PCI procedure
Clinically indicated Target vessel revascularization (TVR)
Time frame: Within 1 year after the index PCI procedure
Clinically indicated Target vessel revascularization (TVR)
Time frame: Within 1 year after the index PCI procedure
Any repeat revascularization
Time frame: Within 1 year after the index PCI procedure
Definite or probable stent thrombosis
Time frame: Within 1 year after the index PCI procedure
Major bleeding
Time frame: Within 1 year after the index PCI procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Derived from this study: PubMed 39691038Jeon HS, Youn YJ, Lee JH, Park YJ, Son JW, Lee JW, Ahn MS, Ahn SG, Kim JY, Yoo BS, Yoon J. Safety and Efficacy of Two Ultrathin Biodegradable Polymer Sirolimus-Eluting Stents in Real-World Practice: Genoss DES Stents Versus Orsiro Stents From a Prospective Registry. Clin Cardiol. 2024 Dec;47(12):e70060. doi: 10.1002/clc.70060.
- Derived from this study: PubMed 39297854Jeon HS, Kim YI, Lee JH, Park YJ, Son JW, Lee JW, Youn YJ, Ahn MS, Kim JY, Yoo BS, Ko SM, Ahn SG. Failed Thrombus Aspiration and Reduced Myocardial Perfusion in Patients With STEMI and Large Thrombus Burden. JACC Cardiovasc Interv. 2024 Oct 14;17(19):2216-2225. doi: 10.1016/j.jcin.2024.07.016. Epub 2024 Sep 18.
- Derived from this study: PubMed 36807273Youn YJ, Jeon HS, Kim YI, Lee JH, Park YJ, Cho DH, Son JW, Lee JW, Ahn MS, Ahn SG, Kim JY, Yoo BS, Lee SH, Yoon J. Impact of the ultra-long 48 mm drug-eluting stent on procedural and clinical outcomes in patients with diffuse long coronary artery disease. Clin Cardiol. 2023 Apr;46(4):416-424. doi: 10.1002/clc.23997. Epub 2023 Feb 20.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the multicenter registry contains potentially identifiable clinical data, and no data-sharing governance framework has been established among the participating institutions.
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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.
Young Jin Youn, M.D., Ph.D. principal investigator
Yonsei University
4 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 and Ischemic Heart Disease (IHD), run by Yonsei University at 4 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 2 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Young Jin Youn, M.D., Ph.D. (+82-33-741-0917, younyj@yonsei.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-oriented composite outcome (POCO) (time frame: Within 1 year after the index PCI 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 NCT02038127, 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 7 Oct 2026.