Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-100
SponsorBon-Kwon Koo
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 19 or older
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
Disqualifiers
Incapable of voluntarily providing informed consent
Allergy or contraindication to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
Cardiogenic shock or cardiac arrest patients
Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
Trial population
Patients with multivessel coronary artery disease who undergo coronary intervention
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
drug-coated balloon
DeviceFor 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
DeviceWhen using drug-eluting stents, the latest 2nd generation drug-eluting stent (Synergy®, Boston Scientific, USA) should be used in accordance with the latest guidelines.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Hybrid strategy2 interventions
Group B: DES only1 intervention
Trial outcomes
Primary outcomes
1
The reclassification rate of the treatment strategy
The reclassification rate according to the change in treatment approach from the default strategy of using only drug-eluting stents (DES-only) to the hybrid strategy of using both drug-coated balloons and drug-eluting stents in the treatment of multivessel coronary artery disease.
Time frame
At the time of procedureSecondary outcomes
1
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy
Time frame
At the time of procedure2
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy
Time frame
At the time of procedure3
Cardiovascular death
Cardiovascular death
Time frame
1 year4
All-cause death
All-cause death
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bon-Kwon Koo
Lead sponsor
Seoul National University Hospital
Sponsor institution
Seoul National University Hospital
Collaborator
St Vincent's Hospital
Collaborator
Uijeongbu St. Mary Hospital
Collaborator
Gachon University Gil Medical Center
Collaborator
Gangnam Severance Hospital
Collaborator
Kyunghee University Medical Center
Collaborator
Keimyung University Dongsan Medical Center
Collaborator
Inje University Ilsan Paik Hospital
Collaborator
Daegu Catholic University Medical Center
Collaborator
Sejong General Hospital
Collaborator
Seoul National University Bundang Hospital
Collaborator
Soonchunhyang University Hospital
Collaborator
Yeungnam University Hospital
Collaborator
Wonju Severance Christian Hospital
Collaborator
Ulsan University Hospital
Collaborator
Ewha Womans University Mokdong Hospital
Collaborator
Inje University
Collaborator
Chonnam National University Hospital
Collaborator
Chung-Ang University Gwangmyeong Hospital
Collaborator
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Collaborator
Ulsan Medical Center
Collaborator
Hanyang University Seoul Hospital
Collaborator
Jeju National University Hospital
Collaborator
KangWon National University Hospital
Collaborator
Uijeongbu Eulji University Hospital
Collaborator
Seoul St. Mary's Hospital
Collaborator
Gyeongsang National University Hospital
Collaborator
Severance Hospital
Collaborator
Chosun University Hospital
Collaborator
Kyungpook National University Hospital
Collaborator
Korea University Anam Hospital
Collaborator
Kyung Hee University Hospital at Gangdong
Collaborator
Ajou University School of Medicine
Collaborator
Source ClinicalTrials.gov