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

NCT07330817 | Not Yet Recruiting

• 1 other identifier: CN-PER-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

A-V fistula; First-In-Man; Ultra-High Pressure Balloon; PTA balloon; Resistant Stenotic Fistula

Outcome Measures

Primary Outcomes (2)

• Technical Success

  Ability to cross the lesion and fully efface the balloon, leaving no residual stenosis (\<30%) evaluated by fistulography

  At the end of the procedure (up to 40 minutes)

• Freedom from procedure-related complications after 1 month

  freedom from adverse events related to the procedure in 1 month follow up period

  1 month

Secondary Outcomes (7)

• Acute Device Success

  At the end of the procedure (up to 40 minutes)

• Clinical Success

  At the end of the procedure (up to 40 minutes)

• Procedural Surgery success

  At the end of hospitalization (assessed up to 5 days)

• Target Lesion Primary Patency

  1 month

• Freedom from target lesion revascularization

  1 month

Study Arms (1)

ULTRAVIOLET UHP PTA

EXPERIMENTAL

Percutaneous transluminal angioplasty with ultra-high-pressure balloon

Device: PTA balloon

Interventions

PTA balloon DEVICE

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

ULTRAVIOLET UHP PTA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients able to understand the purpose of the study, voluntarily agree to participate and signed Informed Consent form
• Patients with impaired haemodialysis access due to narrowed lesions, as indicated by contrast or ultrasound or clinical diagnosis.
• Indications for percutaneous endovascular therapy with diameter stenosis \>50% and fistula's hemodynamic showing abnormalities (thrombosis in the AVF, high venous pressure, re-circulation, abnormal physical examination, decrease in dialysis efficiency, decrease in blood flow through the vascular access)
• Target lesion is a resistant de novo or restenotic lesion
• The target lesion is located in the reflux vein from the anastomotic site of arteriovenous fistula (AVF) to the distal end of the subclavian vein (excluding the anastomotic site of AVF); if there are no target lesions, they should be treated with standard angioplasty balloon before treating the target lesion.

You may not qualify if:

• Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study;
• Patients who are actively participating in another drug or device investigational study, who have not completed the primary endpoint follow-up period;
• Patients who have undergone major surgical procedures (such as open chest surgery, head surgery) within 30 days before being enrolled in the study;
• Patients who plan to undergo major surgical procedures (such as open chest surgery, head surgery) within 30 days after being enrolled in the study;
• Immature AVF (not used for dialysis; due to insufficient inner diameter, inability to ensure successful puncture, and inadequate blood flow, this access has not been used for successful dialysis);
• AVF has been implanted with a stent.

Sponsors & Collaborators

• Cardionovum GmbH: lead

Study Sites (1)

ASST Sette Laghi

Varese, 21100, Italy

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Matteo Tozzi, MD, PhD

  Universita' Insubria, ASST Sette Laghi, Varese, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Silvestri, MSc

CONTACT

+393451016383; paolo.silvestri@cardionovum.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 9, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)