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Not yet recruiting NCT07330817

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

No phase Interventional Arterio-venous Fistula Stenosis of Arteriovenous Dialysis Fistula

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PTA balloon.
Who it may be relevant to
Registry conditions: Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device PTA balloon
    Angioplasty of a resistant stenotic lesion in the arterio-venous fistula

Primary outcome measures

  • Technical Success [Time frame: At the end of the procedure (up to 40 minutes)]
  • Freedom from procedure-related complications after 1 month [Time frame: 1 month]
Secondary outcome measures (7)
  • Acute Device Success [Time frame: At the end of the procedure (up to 40 minutes)]
  • Clinical Success [Time frame: At the end of the procedure (up to 40 minutes)]
  • Procedural Surgery success [Time frame: At the end of hospitalization (assessed up to 5 days)]
  • Target Lesion Primary Patency [Time frame: 1 month]
  • Freedom from target lesion revascularization [Time frame: 1 month]
  • Major Adverse Events (MAE) [Time frame: 1 month]
  • Dialysis Circuit Patency [Time frame: 1 month]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • ASST Sette Laghi — Varese

Identifiers

NCT: NCT07330817 · CN-PER-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗