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Serranator POINT FORCE Registry for PAD and Dysfunctional AV Fistulas/Grafts

This study is a registry, meaning it collects information about how the Serranator® device works in real-world situations. It's for people with Peripheral Artery Disease (PAD), which affects blood flow to your limbs, or those with a dysfunctional (not working well) AV fistula or graft, which are used for dialysis. The study will look at the safety and performance of the Serranator® when used to treat blockages in arteries or problems with dialysis access. To join, you must be 18 or older and your doctor plans to treat you with the Serranator® for these conditions. The main goal is to see how well the device performs right after the procedure. The current recruitment status is unclear.

Study design
This is an observational study that aims to enroll 500 participants. It collects data under standard medical care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary performance endpoint is measured around the time of the procedure (peri-procedural).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06687590

Serranator POINT FORCE Registry

Recruiting
Not specifiedAges 18+Observational
Cagent Vascular LLC
~500 participants
Updated 2026-05-07 on ClinicalTrials.gov
What's tested:Peripheral balloon angioplasty

At a glance

Recruiting sites
18 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Performance Endpoint
Measured over Peri-procedural

Conditions

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

Explore related trials

Arteriovenous FistulaArteriovenous graftPeripheral Artery Disease

Where it's being run

19 sites across 15 states
Florida2
New Jersey2
Ohio2
Pennsylvania2
Arizona1
California1
Connecticut1
District of Columbia1

Who to contact

Alexis Shewfelt
[email protected]
6502086743
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 \> 18.
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

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.

What this trial measures

  • Performance EndpointPeri-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.