Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion

Ulsan Medical Center

Status: Enrolling

Conditions: Drug-coated Balloon

Treatments: Device: drug-coated balloon

Study type: Observational

Funder types: Other

Identifiers

NCT04619277

USH-20-004 (Registry Identifier)

Details and patient eligibility

About

This study is the international multicenter registry for drug-coated balloon treatment for de novo coronary lesion.

Full description

There is lots of evidence that DCBs result in lower rates of restenosis, thrombosis, and better long-term outcomes when used for PCI of in-stent restenosis (ISR) compared to plain old balloon angioplasty (POBA) or additional stenting with drug-eluting stent (DES). DCB-only approach studies for de novo coronary lesion cases are scarce, but a recent registry data suggested it was a feasible and well-tolerated treatment method if the pre-dilation result is good. Therefore, the aim of this study was to evaluate the safety and efficacy in terms of angiographic and clinical outcomes of a DCB-only approach for de novo coronary lesions.

Enrollment: 10,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• de novo coronary artery disease

Exclusion criteria

• unstable hemodynamics at presentation
• life expectancy <1 year

Trial design

10,000 participants in 7 patient groups

Ulsan Medical Center

Description:

Division of Cardiology, Department of Internal Medicine, Ulsan Medical Center, Ulsan, South Korea

Treatment:

Device: drug-coated balloon

Queen Elizabeth Hospital

Description:

Cardiology Department and Clinical Research Center, Queen Elizabeth Hospital II, Kota Kinabalu, Malaysia

Treatment:

Device: drug-coated balloon

Pecking University Shougand Hospital

Description:

Department of Cardiology, Peking University Shougang Hospital, Peking, China

Treatment:

Device: drug-coated balloon

Ulsan University Hospital

Description:

Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea

Treatment:

Device: drug-coated balloon

Kangwon National University School of Medicine

Description:

Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, South Korea

Treatment:

Device: drug-coated balloon

Korea University Guro Hospital

Description:

Cardiovascular Center, Department of Cardiology, Korea University Guro Hospital, Seoul, South Korea

Treatment:

Device: drug-coated balloon

Korea University Ansan Hospital

Description:

Department of Cardiology, Korea University Ansan Hospital, Ansan, South Korea

Treatment:

Device: drug-coated balloon