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

NCT ID: NCT07330817

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-02-28

Brief Summary

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

Detailed Description

First-In-Man Single Site study to assess safety and efficacy of ultra-high pressure PTA balloon called ULTRAVIOLET UHP PTA in treating resistant stenotic lesions in arterio-venous fistula of dialysis patients.

Conditions

Arterio-venous Fistula; Stenosis of Arteriovenous Dialysis Fistula

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ULTRAVIOLET UHP PTA

Percutaneous transluminal angioplasty with ultra-high-pressure balloon

Group Type: EXPERIMENTAL

PTA balloon

Intervention Type: DEVICE

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

Interventions

PTA balloon

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardionovum GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matteo Tozzi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universita' Insubria, ASST Sette Laghi, Varese, Italy

Locations

ASST Sette Laghi

Varese, , Italy

Countries

Italy

Central Contacts

Paolo Silvestri, MSc

Role: CONTACT

paolo.silvestri@cardionovum.com

+393451016383

Facility Contacts

Matteo Tozzi, MD, PhD

Role: primary

matteo.tozzi@me.com

0039 0332 393259

Other Identifiers

CN-PER-001

Identifier Type: -

Identifier Source: org_study_id