First-In-Man Single Arm Prospective Study to assess the safety and efficacy of ULTRAVIOLET UHP PTA balloon.
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
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;
Single group
PTA balloon
DeviceAngioplasty of a resistant stenotic lesion in the arterio-venous fistula
Technical Success
Ability to cross the lesion and fully efface the balloon, leaving no residual stenosis (\<30%) evaluated by fistulography
Freedom from procedure-related complications after 1 month
freedom from adverse events related to the procedure in 1 month follow up period
Acute Device Success
successful delivery, balloon inflation, deflation, and retrieval of the intact study device without burst below rated burst pressure
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
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
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)
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This trial is not recruiting at the moment. You can still explore other options:
