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A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis

NCT07330817 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-01-09

No results posted yet for this study

Summary

First-In-Man Single Arm Prospective Study to assess the safety and efficacy of ULTRAVIOLET UHP PTA balloon.

Conditions

  • Arterio-venous Fistula
  • Stenosis of Arteriovenous Dialysis Fistula

Interventions

DEVICE

PTA balloon

Angioplasty of a resistant stenotic lesion in the arterio-venous fistula

Sponsors & Collaborators

  • Cardionovum GmbH

    lead INDUSTRY

Principal Investigators

  • Matteo Tozzi, MD, PhD · Universita' Insubria, ASST Sette Laghi, Varese, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-01-31
Completion
2027-02-28

Countries

  • Italy

Study Locations

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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 NCT07330817 on ClinicalTrials.gov