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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03538392

Enrollment

Registered

2018-05-29

Start date

2019-09-30

Completion date

2019-12-31

Last updated

2020-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterio-venous Fistula, Arteriovenous Graft, Peripheral Arterial Disease

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.

Interventions

DEVICESerranator® Alto

Serranator® Alto PTA Serration Balloon Catheter

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026