NCT03538392

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

Post Market Clinical Follow-up Study - PMCF Study, Serranator® Alto

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Cagent Vascular LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease
• Arterio-venous Fistula
• Arteriovenous Graft

Interventions

Type	Name	Description
DEVICE	Serranator® Alto	Serranator® Alto PTA Serration Balloon Catheter

Timeline

• Start date: 2019-09-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-05-29
• Last updated: 2020-04-10

Regulatory

• FDA-regulated device study