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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Arterio-venous Fistula; Stenosis of Arteriovenous Dialysis Fistula
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paolo Silvestri, MSc; Phone Number: +393451016383; Email: paolo.silvestri@cardionovum.com

Study Locations

• Italy
  • Varese, Italy, 21100
    • ASST Sette Laghi
    • Contact: Matteo Tozzi, MD, PhD; Phone Number: 0039 0332 393259; Email: matteo.tozzi@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ULTRAVIOLET UHP PTA; Percutaneous transluminal angioplasty with ultra-high-pressure balloon	Device: PTA balloon; Angioplasty of a resistant stenotic lesion in the arterio-venous fistula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Device Success	successful delivery, balloon inflation, deflation, and retrieval of the intact study device without burst below rated burst pressure	At the end of the procedure (up to 40 minutes)
Clinical Success	after intervention, the function of hemodialysis access is improved, dialysis function is restored, and at least one complete dialysis session has been completed	At the end of the procedure (up to 40 minutes)
Procedural Surgery success	Once technical success has been achieved, no major adverse events (MAE) occurred during the procedure or hospitalization, including death, stroke, thrombosis, allergic reactions, or pulmonary disease	At the end of hospitalization (assessed up to 5 days)
Target Lesion Primary Patency	Primary patency rate refers to the peak systolic velocity ratio (PSVR) measured by Doppler ultrasound (DUS) ≤ 2.0, which confirms the absence of restenosis and does not require clinically driven target lesion revascularization (CD-TLR)	1 month
Freedom from target lesion revascularization	Clinical symptoms and dialysis indicators indicate that dialysis cannot be successfully performed, and the target lesion location (confirmed by Doppler ultrasound) +/-5 mm proximal/distal requires re-intervention surgery	1 month
Major Adverse Events (MAE)	Occurrence of major adverse events (MAE)	1 month
Dialysis Circuit Patency	Patency of the whole patency circuit evaluated at Doppler Ultra-Sound (DUS)	1 month

Collaborators and Investigators

• Sponsor: Cardionovum GmbH
• Investigators: Principal Investigator: Matteo Tozzi, MD, PhD, Universita' Insubria, ASST Sette Laghi, Varese, Italy

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: A-V fistula; First-In-Man; Ultra-High Pressure Balloon; PTA balloon; Resistant Stenotic Fistula
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Fistula; Arteriovenous Malformations; Vascular Fistula; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Arteriovenous Fistula
• Other Study ID Numbers: CN-PER-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No