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NCT Number: NCT06687590

Serranator POINT FORCE Registry

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.

Recruiting

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Key information

Conditions

Peripheral Artery Disease (PAD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Dysfunctional AV Fistula Dysfunctional AV Graft Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HonorHealth, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 > 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 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.

Treatment and study plan

peripheral balloon angioplasty

Device

Serration balloon angioplasty of iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistula

Primary outcomes

  1. 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.

Secondary outcomes

  1. Safety Endpoint

    Time frame: Peri-procedural

    Major Adverse Events (MAE) until discharge, defined as all amputations and any re-intervention (surgical or endovascular) in the target limb.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexis Shewfelt

CONTACT

[email protected]

6502086743

Sponsors and collaborators

Lead sponsor

Cagent Vascular LLC

Industry

Collaborators

  • Julius Clinical
  • Yale Cardiovascular Research Group

Registry information

Official study title

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

Acronym: POINT FORCE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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