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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-30

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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

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Peripheral Arterial Disease Arterio-venous Fistula Arteriovenous Graft

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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PAD

Serranator® Alto

Intervention Type DEVICE

Serranator® Alto PTA Serration Balloon Catheter

AV Fistula

Serranator® Alto

Intervention Type DEVICE

Serranator® Alto PTA Serration Balloon Catheter

AV Graft

Serranator® Alto

Intervention Type DEVICE

Serranator® Alto PTA Serration Balloon Catheter

Interventions

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Serranator® Alto

Serranator® Alto PTA Serration Balloon Catheter

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No