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

Cagent Vascular

Status: Withdrawn

Conditions: Arterio-venous Fistula; Arteriovenous Graft; Peripheral Arterial Disease

Treatments: Device: Serranator® Alto

Study type: Observational

Funder types: Industry

Identifiers

NCT03538392

Serranator® Alto PMCF Study

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Subject requires angioplasty
• Subject has a lesion in the iliac, femoral, iliofemoral, popliteal artery, or obstructive lesion of native or synthetic arteriovenous dialysis fistulae as per the product indications for use

Trial design

0 participants in 3 patient groups

PAD

Treatment:

Device: Serranator® Alto

AV Fistula

Treatment:

Device: Serranator® Alto

AV Graft

Treatment:

Device: Serranator® Alto