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Recruiting NCT06687590

Serranator POINT FORCE Registry

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peripheral balloon angioplasty.
Who it may be relevant to
Registry conditions: Peripheral Artery Disease (PAD), Dysfunctional AV Fistula, Dysfunctional AV Graft. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

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

Primary outcome measures

  • Performance Endpoint [Time frame: Peri-procedural]
Secondary outcome measures (1)
  • Safety Endpoint [Time frame: Peri-procedural]

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 > 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 19 centers
  • HonorHealth — Scottsdale
  • Cedars-Sinai Medical Center — Los Angeles
  • Hartford HealthCare — Hartford
  • MedStar Washington Hospital / MedStar Montgomery — Washington D.C.
  • Manatee Memorial — Bradenton
  • Radiology and Imaging Specialists — Lakeland
  • Henry Ford Health — Detroit
  • Barnes Jewish — St Louis
  • … and 11 more centers

Identifiers

NCT: NCT06687590 · CSP-0696

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗