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Serranator POINT FORCE Registry

NCT06687590 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

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

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

Sponsors & Collaborators

  • Yale Cardiovascular Research Group

    collaborator OTHER

  • Julius Clinical

    collaborator INDUSTRY

  • Cagent Vascular LLC

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-22
Primary Completion
2026-06-30
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06687590 on ClinicalTrials.gov