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NOT YET RECRUITING
NCT07391033

The PICCOLETO XI A-PREP Study

Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS

View on ClinicalTrials.gov

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.

Official title: Impact of Lesion PREParation With Modifying Balloons During Drug-coated Balloon (DCB) Angioplasty for In-stent Restenosis (ISR) - PICCOLETO XI A-PREP Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2026-06-01

Completion Date

2028-06-01

Last Updated

2026-02-05

Healthy Volunteers

No