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

NCT03538392 | Withdrawn FDA Device

• 1 other identifier: Serranator® Alto PMCF Study
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Arterial Disease; Arterio-venous Fistula; Arteriovenous Graft

Outcome Measures

Primary Outcomes (1)

• Performance

  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.

  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.

Secondary Outcomes (1)

• Collection of device related Major Adverse Events (MAE) until discharge

  Within 12-24 hours post-procedure or prior to hospital discharge, whichever occurs first

Study Arms (3)

PAD

Device: Serranator® Alto

AV Fistula

Device: Serranator® Alto

AV Graft

Device: Serranator® Alto

Interventions

Serranator® Alto DEVICE

Serranator® Alto PTA Serration Balloon Catheter

AV Fistula; AV Graft; PAD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of subjects with claudication or ischemic rest pain, requiring dilatation of lesions, in the iliac or femoropopliteal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae.

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cagent Vascular LLC: lead

MeSH Terms

Conditions

Peripheral Arterial Disease; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Vascular Fistula; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 29, 2018
• Study Start: September 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 10, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share