Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

• Capable of understanding the risks and benefits of participating in the study and providing informed consent

Locations
Other Locations
Republic of Korea
Bon-Kwon Koo
RECRUITING
Seoul
Contact Information
Primary
Bon-Kwon Koo, MD, PhD
bkkoo@snu.ac.kr
+82-2-2072-2062
Time Frame
Start Date: 2023-09-18
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 500
Treatments
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.
DES only
The patient undergoes percutaneous coronary intervention with drug-eluting stents only in the coronary artery lesion.
Related Therapeutic Areas
Sponsors
Collaborators: Yeungnam University Hospital, St Vincent's Hospital, Uijeongbu Eulji Medical Center, Eulji University, Ajou University School of Medicine, Ulsan University Hospital, Chung-Ang University Gwangmyeong Hospital, Daegu Catholic University Medical Center, KangWon National University Hospital, Gachon University Gil Medical Center, Sejong General Hospital, Uijeongbu St. Mary Hospital, Chosun University Hospital, Soonchunhyang University Hospital, Hanyang University Seoul Hospital, Inje University Ilsan Paik Hospital, Kyungpook National University Hospital, Seoul National University Bundang Hospital, Seoul National University Hospital, Chonnam National University Hospital, Gyeongsang National University Hospital, Ewha Womans University Mokdong Hospital, Seoul St. Mary's Hospital, Keimyung University Dongsan Medical Center, Kyung Hee University Hospital at Gangdong, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Ulsan Medical Center, Kyunghee University Medical Center, Inje University, Severance Hospital, Korea University Anam Hospital, Wonju Severance Christian Hospital, Jeju National University Hospital, Gangnam Severance Hospital
Leads: Bon-Kwon Koo

This content was sourced from clinicaltrials.gov