Post Market Clinical Follow-up Study - PMCF Study, Serranator® Alto
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Cagent Vascular LLC
- Primary Endpoint
- Performance
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Performance
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.
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.
Secondary Outcomes
- Collection of device related Major Adverse Events (MAE) until discharge(Within 12-24 hours post-procedure or prior to hospital discharge, whichever occurs first)