The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® Alto in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.
Single Arm, multi-center, device registry study capturing de-identified data on a minimum of 100 subjects with peripheral artery disease (PAD) and/or dysfunctional native or synthetic arteriovenous dialysis fistulae. The study will capture acute angiographic data.
Study Type
OBSERVATIONAL
Serranator® Alto PTA Serration Balloon Catheter
Performance
Device Success defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device(s) with a diameter stenosis of \<50% by visual assessment at the intended target site after using the Serranator® device.
Time frame: The registry will collect acute procedural data through hospital discharge, no additional follow up is required. Performance data will be summarized after enrollment is complete, estimated to be 1 year.
Collection of device related Major Adverse Events (MAE) until discharge
Safety defined as incidence of device related MAE, defined as amputations or re-interventions (surgical or endovascular)
Time frame: Within 12-24 hours post-procedure or prior to hospital discharge, whichever occurs first
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