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

Starting soon · Not applicable

Conditions studied: Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula

In brief

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

Key facts

Study ID

NCT07330817

Run by

Cardionovum GmbH

People needed

35

Starts

2026-02-01

Expected to finish

2027-02-01

Last updated by the study team

2026-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• ASST Sette Laghi — Varese, Italy

Full record on ClinicalTrials.gov

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