Post-Market Clinical Follow-up Study of the Serranator PTA Serration Balloon Catheter for Peripheral Artery Disease and Dialysis Fistula Treatment

What this Trial Is About

Researchers are collecting observational data to evaluate the safety and performance of the Serranator4 balloon catheter in treating peripheral artery disease PAD and dysfunctional native or synthetic arteriovenous dialysis fistulae. This registry study observes patients treated under routine medical care to gather real-world evidence for clinical evaluation. Participants will undergo serration balloon angioplasty targeting arteries such as the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and pedal arteries, or dysfunctional dialysis fistulae. The study includes subjects with claudication or ischemic rest pain who have new or recurrent lesions in these areas. During the study, data on peri-procedural performance and safety endpoints will be collected while participants receive standard care. The researchers will monitor outcomes related to the devices use in real-world settings. Participation involves observation and data gathering without altering usual treatment, continuing until the study ends in August 2026.

Serranator POINT FORCE Registry