Clinical trial NCT06104033: Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease
Official title: Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Multi Vessel Coronary Artery Disease
Keywords: Coronary artery disease
Multivessel coronary artery disease
Percutaneous coronary intervention
Drug-coated balloon
Drug-eluting stent
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: St Vincent's Hospital
name: Uijeongbu St. Mary Hospital
name: Gachon University Gil Medical Center
name: Gangnam Severance Hospital
name: Kyunghee University Medical Center
name: Keimyung University Dongsan Medical Center
name: Inje University Ilsan Paik Hospital
name: Daegu Catholic University Medical Center
name: Sejong General Hospital
name: Seoul National University Bundang Hospital
name: Soonchunhyang University Hospital
name: Yeungnam University Hospital
name: Wonju Severance Christian Hospital
name: Ulsan University Hospital
name: Ewha Womans University Mokdong Hospital
name: Inje University
name: Chonnam National University Hospital
name: Chung-Ang University Gwangmyeong Hospital
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Ulsan Medical Center
name: Hanyang University Seoul Hospital
name: Jeju National University Hospital
name: KangWon National University Hospital
name: Uijeongbu Eulji Medical Center, Eulji University
name: Seoul St. Mary's Hospital
name: Gyeongsang National University Hospital
name: Severance Hospital
name: Chosun University Hospital
name: Kyungpook National University Hospital
name: Korea University Anam Hospital
name: Kyung Hee University Hospital at Gangdong
name: Ajou University School of Medicine
First posted: 2023-10-27
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with multivessel coronary artery disease who undergo coronary intervention

Brief summary: This study is a prospective, multicenter, open-label, observational study to investigate the impact of using drug-coated balloons (DCBs) in the treatment of coronary artery lesions in patients with multivessel coronary artery disease (MVD), as opposed to the default strategy of using only drug-eluting stents (DES). The investigators aim to assess changes in clinical practice towards a hybrid treatment strategy (DES and DCB) and its effects on clinical outcomes.


Eligibility criteria: Inclusion Criteria:

1. Age 19 or older
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:

1. Incapable of voluntarily providing informed consent
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

Primary outcomes:
measure: The reclassification rate of the treatment strategy
timeFrame: At the time of procedure
Secondary outcomes:
measure: Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy
timeFrame: At the time of procedure
measure: Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy
timeFrame: At the time of procedure
measure: Cardiovascular death
timeFrame: 1 year
measure: All-cause death
timeFrame: 1 year
measure: Non-fatal myocardial infarction (MI)
timeFrame: 1 year
measure: Target vessel MI excluding periprocedural MI
timeFrame: 1 year
measure: Target vessel MI including periprocedural MI
timeFrame: 1 year
measure: Clinically indicated target lesion revascularization
timeFrame: 1 year
measure: Clinically indicated target vessel revascularization
timeFrame: 1 year
measure: Any revascularization
timeFrame: 1 year
measure: Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition
timeFrame: 1 year
measure: Cardiovascular death or target vessel MI
timeFrame: 1 year
measure: All-cause death or non-fatal MI
timeFrame: 1 year
measure: Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization
timeFrame: 1 year
measure: Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization
timeFrame: 1 year
measure: Cardiovascular death, target vessel MI, or vessel or stent thrombosis
timeFrame: 1 year
measure: All-cause death, non-fatal MI, or clinically indicated target vessel revascularization
timeFrame: 1 year
measure: Major bleeding events (BARC type 2, 3, or 5)
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Bon-Kwon Koo
Study officials:
affiliation: +82-2-2072-2062
name: Bon-Kwon Koo, MD, PhD
role: STUDY_CHAIR
References: