Investigation to Assess the Effects of Drug-COATED Balloons for Treatment of Plaques Erosions Causing Acute Coronary Syndromes

Sponsor
3W-Research Collaboration Group
Study ID
NCT07783880
Status
Not Yet Recruiting

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Conditions

  • Computed Tomography
  • Coronary Computed Tomographic Angiography
  • Medical Treatment
  • Myocardial Infarction
  • Optical Coherence Tomography (OCT)
  • Percutaneous Coronary Intervention (PCI)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PCI with size matched DCB — DEVICE
    Subjects will be treated with PCI with size matched DCB (SeQuent)
  • GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy — DRUG
    GP IIbIIIa inhibitor or heparin \& dual antiplatelet therapy

Study Details

Drug eluting balloon angioplasty might be a better alternative than medical treatment or stenting in subjects with plaque erosion, which is the second most common cause of myocardial infarction. The main objective of this pilot study is to gain clear insights on the effect of percutaneous coronary intervention (PCI) with size matched DCB (SeQuent) as compared to treatment with GP IIbIIIa inhibitor or heparin \& dual antiplatelet therapy in a predominantly Caucasian population at 2 days and at 1 year after the procedure.

Key Dates

First listed
Aug 25, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Oct 1, 2029
Completion
Jan 1, 2030

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: PCI with size matched DCB
    PCI with size matched drug-coated balloon
  • Placebo Comparator: GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy

Primary Outcome Measure

Optical Coherence Tomography (OCT)-assessed Minimum Lumen Area (MLA) during the control procedure [ Time Frame: Day 2-3 ]

Central Contacts

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