The PICCOLETO XI A-PREP Study

Sponsor
Fondazione Ricerca e Innovazione Cardiovascolare ETS
Study ID
NCT07391033
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease
  • In-Stent Coronary Artery Restenosis

Eligibility Criteria

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

Study Details

To compare the angiographic and clinical outcomes of aggressive versus standard balloon preparation during drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR). The study will evaluate whether more aggressive lesion preparation with cutting/scoring/OPN balloons improves outcomes compared to standard preparation with semi-compliant or non-compliant balloons.

Key Dates

First listed
Feb 5, 2026
Start date
Jun 1, 2026
Status verified
Jan 2026
Primary completion
Dec 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Aggressive Lesion Preparation
    Patients who underwent lesion preparation using cutting/Wolverine balloons, scoring balloons (any brand), and/or OPN balloons prior to DCB angioplasty for ISR.
  • Arm: Standard Lesion Preparation
    Patients who underwent lesion preparation using semi-compliant balloons and/or non-compliant balloons prior to DCB angioplasty for ISR.

Primary Outcome Measure

Major Adverse Cardiovascular Events (MACE) [ Time Frame: 12 months ]

Central Contacts

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