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NCT05550233: DCB-LVD

Drug-coated Balloons in Big de Novo Coronary Disease

Status unknown NA Last updated 8 February 2023
What this trial tests

NA trial testing drug-coated balloon in Coronary Heart Disease in 240 participants. Status unknown.

Timeline
1 October 2022
Primary endpoint
31 December 2024
31 December 2024

Quick facts

Lead sponsorBeijing Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment240
Start date1 October 2022
Primary completion31 December 2024
Estimated completion31 December 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Beijing Hospital

Who can join

18 and older, any sex, with Coronary Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A prospective, multicenter, randomized controlled, open-label, non-inferiority trial. Plan to recruit 240 patients whose lesions are de novo coronary artery disease (reference vessel diameter ≥ 3.0 mm), diameter stenosis ≥ 75% with ischemic symptoms or objective evidence of ischemia (ECG, cardionuclide, or FFR), and are suitable for implantation DES or DCB. After successful preconditioning, patients were randomly assigned to two PCI treatment groups(drug-coated balloon or drug-eluted stent) in a 1:1 ratio. The safety and efficacy of drug-coated balloons in PCI treatment of de novo coronary artery lesions (reference diameter 3.0 mm and above) were evaluated by comparing the late lumen loss of two groups of subjects in 12 months.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immediate and follow-up outcomes of drug-coated balloon angioplasty in de novo long lesions on large coronary arteries.
    Leone PP, Oliva A, Regazzoli D, Gitto M, et al · · 2023 · cited 23× · PMID 37670668 · DOI 10.4244/eij-d-23-00502
  2. Exploring New Avenues for De Novo Coronary Artery Disease: Next Steps Forward With Drug-Coated Balloons.
    Kang DO, Kim SW, Jeong YH. · · 2024 · cited 2× · PMID 39101108 · DOI 10.1016/j.jacasi.2024.05.006
  3. A New Frontier for Drug-Coated Balloons: Treatment of "De Novo" Stenosis in Large Vessel Coronary Artery Disease.
    Sciahbasi A, Mazza TM, Pidone C, Samperi S, et al · · 2024 · cited 1× · PMID 38592181 · DOI 10.3390/jcm13051320
  4. The longest way round is the shortest way home: drug-coated balloons for long lesions in large coronary arteries.
    Gonzalo N, Shabbir A. · · 2023 · cited 1× · PMID 38105718 · DOI 10.4244/eij-e-23-00043
  5. Drug-coated balloons in complex large-vessel coronary artery disease: a comprehensive review of current evidence and future perspectives.
    Gitto M, Gabrielli A, Leone PP, Sanz-Sanchez J, et al · · 2026 · PMID 41815903 · DOI 10.3389/fcvm.2026.1731952
  6. Contemporary Percutaneous Coronary Intervention in Diabetic Patients.
    Tartaglia F, Filiberti G, Bernardini V, Gitto M, et al · · 2025 · PMID 41524061 · DOI 10.31083/rcm44861

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Other Beijing Hospital trials

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