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

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

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Overview

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

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.

Eligibility

Inclusion Criteria:

  • de novo coronary artery disease

Exclusion Criteria:

  • unstable hemodynamics at presentation
  • life expectancy <1 year

Study details
    Drug-coated Balloon

NCT04619277

Ulsan Medical Center

27 January 2024

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