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NCT Number: NCT04619277

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

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

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Key information

Conditions

Drug-coated Balloon

Sex eligibility

All sexes

Study type

Observational

Primary location

Ulsan Medical Center

Ulsan, 44686, South Korea

Location status: Recruiting

Location contact

Eun-Seok Shin

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • de novo coronary artery disease

Exclusion criteria

  • unstable hemodynamics at presentation
  • life expectancy <1 year

Treatment and study plan

Drug-coated Balloon

Device

drug-coated balloon

Primary outcomes

  1. Major adverse cardiac events at 12 months

    Time frame: 12 months

    Primary endpoint is major adverse cardiac events (MACE is a composite of cardiac death, non-fatal myocardial infarction, target-vessel revascularization and major bleeding [BARC type 3 to 5]) at 12 months.

    • Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death.
    • Target vessel Revascularization: TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel.

Secondary outcomes

  1. Angiographic and clinical outcomes

    Time frame: 12, 24, 36 months

    • MACE at 12, 24, 36 months
    • The single components of the primary endpoint after 12, 24, 36 months. Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding after 12, 24, 36 months.1 (All events will be adjudicated by an independent Critical Events Committee).
    • Possible, probable, and definite stent thrombosis defined according to the ARC criteria after 12, 24, 36 months.
    • Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation
    • Cost-effectiveness of DCB vs. DES after 12, 24, 36 months.
    • All-cause death ⑥ Stroke (ischemic and hemorrhagic)
    • Angina severity measured with Seattle Angina Questionnaires at 12, 24 months
    • Total procedure time, fluoroscopy time, contrast volume, number of stents used ⑨ DAPT duration ⑩ Periprocedural MI rate ⑪ Sex difference in MACE between DCB vs. DES ⑫ Comparison of MACE between DCB vs. DES in DM patients

Study contacts

Contact information is provided by the study sponsor or research team.

Eun-Seok Shin

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Ulsan Medical Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2030
Study completion
2030
First posted
Nov 6, 2020
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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