First-In-Man Single Arm Prospective Study to assess the safety and efficacy of ULTRAVIOLET UHP PTA balloon.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Angioplasty of a resistant stenotic lesion in the arterio-venous fistula
ASST Sette Laghi
Varese, Italy
Technical Success
Ability to cross the lesion and fully efface the balloon, leaving no residual stenosis (\<30%) evaluated by fistulography
Time frame: 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
Time frame: 1 month
Acute Device Success
successful delivery, balloon inflation, deflation, and retrieval of the intact study device without burst below rated burst pressure
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 1 month
Freedom from target lesion revascularization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: 1 month
Major Adverse Events (MAE)
Occurrence of major adverse events (MAE)
Time frame: 1 month
Dialysis Circuit Patency
Patency of the whole patency circuit evaluated at Doppler Ultra-Sound (DUS)
Time frame: 1 month