POst-Market ClINical Follow-up STudy of the SerranatOR PTA Serration Balloon CathEter

Cagent Vascular LLC1 site in 1 country500 target enrollmentJanuary 22, 2025

ConditionsPeripheral Artery Disease (PAD)Dysfunctional AV Fistula Dysfunctional AV Graft

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Artery Disease (PAD)
Sponsor: Cagent Vascular LLC
Enrollment: 500
Locations: 1
Primary Endpoint: Performance Endpoint
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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® in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.

The data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.

Registry

clinicaltrials.gov

Start Date

January 22, 2025

End Date

December 31, 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Cagent Vascular LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects intended to be treated with Serranator® for de-novo or restenotic lesions of the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae.
•Subjects presenting with claudication or critical limb-threatening ischemia (CLTI) by Rutherford Clinical Category 3, 4, 5, or 6 of the target limb.
•Age of subject is \>
•Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form.

Exclusion Criteria

•Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Serranator® as per Instructions for Use (IFU) or investigator's opinion.
•Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.

Outcomes

Primary Outcomes

Performance Endpoint

Time Frame: Peri-procedural

Device Success defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device(s) with a post- Serranator® residual stenosis of ≤30% by angiographic core laboratory assessment at the intended target lesion.