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The PICCOLETO XI A-PREP Study

NCT07391033 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-02-05

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Fondazione Ricerca e Innovazione Cardiovascolare ETS

    lead OTHER

Principal Investigators

  • Bharat Khialani, MD · Tan Tock Seng Hospital, National Healthcare Group, Singapore

  • Filippo Luca Gurgoglione, MD, PhD · Department of Cardiology, Parma University Hospital, Parma, Italy

  • Bernardo Cortese, MD · Fondazione Ricerca e Innovazione Cardiovascolare ETS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-12-01
Completion
2028-06-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07391033 on ClinicalTrials.gov