Serranator® Alto Post Market Clinical Follow Up (PMCF) Study

Withdrawn

• Conditions: Arterio-venous Fistula; Peripheral Arterial Disease; Arteriovenous Graft
• Interventions: Device: Serranator® Alto

• Registration Number: NCT03538392
• Lead Sponsor: Cagent Vascular LLC

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.

Study Timeline

• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-05-29
• Status Verified: 2019-07
• Study Start: 2019-09
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PAD	Serranator® Alto	-
AV Fistula	Serranator® Alto	-
AV Graft	Serranator® Alto	-

Primary Outcome Measures

Name	Time	Method
Performance	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 Outcome Measures

Name	Time	Method
Collection of device related Major Adverse Events (MAE) until discharge	Within 12-24 hours post-procedure or prior to hospital discharge, whichever occurs first	Safety defined as incidence of device related MAE, defined as amputations or re-interventions (surgical or endovascular)