NCT04619277

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Ulsan Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Drug-coated Balloon

Interventions

Type	Name	Description
DEVICE	drug-coated balloon	drug-coated balloon

Timeline

• Start date: 2011-04-22
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2020-11-06
• Last updated: 2024-08-15

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study