Serranator POINT FORCE Registry

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

Serranator POINT FORCE Registry

Condition
Peripheral Artery Disease (PAD)
Intervention / Treatment

-

Contacts and Locations

Dallas

UT Southwestern, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cagent Vascular LLC,

Study Record Dates

2026-12-31