Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease
NCT ID: NCT06104033
Last Updated: 2023-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2023-09-18
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hybrid strategy
The patient undergoes percutaneous coronary intervention with drug-coated balloons and drug-eluting stents or drug-coated balloons only in the coronary artery lesion.
drug-coated balloon
For the procedure, the drug-coated balloon (Agent®, Boston Scientific, USA) that can be used for both de-novo coronary lesions and in-stent restenosis lesions is used.
drug-eluting stent
When using drug-eluting stents, the latest 2nd generation drug-eluting stent (Synergy®, Boston Scientific, USA) should be used in accordance with the latest guidelines.
DES only
The patient undergoes percutaneous coronary intervention with drug-eluting stents only in the coronary artery lesion.
drug-eluting stent
When using drug-eluting stents, the latest 2nd generation drug-eluting stent (Synergy®, Boston Scientific, USA) should be used in accordance with the latest guidelines.
Interventions
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drug-coated balloon
For the procedure, the drug-coated balloon (Agent®, Boston Scientific, USA) that can be used for both de-novo coronary lesions and in-stent restenosis lesions is used.
drug-eluting stent
When using drug-eluting stents, the latest 2nd generation drug-eluting stent (Synergy®, Boston Scientific, USA) should be used in accordance with the latest guidelines.
Eligibility Criteria
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Inclusion Criteria
2. Multivessel coronary artery disease patients requiring coronary intervention
* Stenosis of 2 or more major coronary arteries or major coronary artery branches (Vessel size ≥2.5mm) with diameter stenosis ≥50% or fractional flow reserve ≤0.80 requiring repeat revascularization
* Having stenotic lesions requiring revascularization with a vessel size of 2.5mm to 3.0mm
3. Capable of understanding the risks and benefits of participating in the study and providing informed consent
Exclusion Criteria
2. Allergy or contraindication to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
3. Cardiogenic shock or cardiac arrest patients
4. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%)
5. Patients for whom coronary artery bypass surgery is prioritized over coronary artery intervention
6. Patients with severe valvular heart disease requiring open heart surgery
7. Pregnant or lactating women
19 Years
100 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
St Vincent's Hospital
OTHER
Uijeongbu St. Mary Hospital
OTHER
Gachon University Gil Medical Center
OTHER
Gangnam Severance Hospital
OTHER
Kyunghee University Medical Center
OTHER
Keimyung University Dongsan Medical Center
OTHER
Inje University Ilsan Paik Hospital
OTHER
Daegu Catholic University Medical Center
OTHER
Sejong General Hospital
OTHER
Seoul National University Bundang Hospital
OTHER
Soonchunhyang University Hospital
OTHER
Yeungnam University Hospital
OTHER
Wonju Severance Christian Hospital
OTHER
Ulsan University Hospital
OTHER
Ewha Womans University Mokdong Hospital
OTHER
Inje University
OTHER
Chonnam National University Hospital
OTHER
Chung-Ang University Gwangmyeong Hospital
OTHER
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
OTHER
Ulsan Medical Center
OTHER
Hanyang University Seoul Hospital
OTHER
Jeju National University Hospital
OTHER
KangWon National University Hospital
OTHER
Uijeongbu Eulji Medical Center, Eulji University
UNKNOWN
Seoul St. Mary's Hospital
OTHER
Gyeongsang National University Hospital
OTHER
Severance Hospital
OTHER
Chosun University Hospital
OTHER
Kyungpook National University Hospital
OTHER
Korea University Anam Hospital
OTHER
Kyung Hee University Hospital at Gangdong
OTHER
Ajou University School of Medicine
OTHER
Bon-Kwon Koo
OTHER
Responsible Party
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Bon-Kwon Koo
Professor
Principal Investigators
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Bon-Kwon Koo, MD, PhD
Role: STUDY_CHAIR
+82-2-2072-2062
Locations
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Bon-Kwon Koo
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2306-138-1440
Identifier Type: -
Identifier Source: org_study_id
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