Serranator POINT FORCE Registry (POINT FORCE)

May 1, 2026 updated by: Cagent Vascular LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Donald Baril
        • Contact:
    • Connecticut
      • Hartford, Connecticut, United States, 06102
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital / MedStar Montgomery
        • Principal Investigator:
          • Nelson Bernardo, MD
        • Contact:
        • Principal Investigator:
          • Kyle B Reynolds, MD
    • Florida
      • Bradenton, Florida, United States, 34208
      • Lakeland, Florida, United States, 33801
        • Recruiting
        • Radiology and Imaging Specialists
        • Contact:
        • Principal Investigator:
          • Michael Campbell
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • Principal Investigator:
          • Thomas Davis, MD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Barnes Jewish
        • Principal Investigator:
          • Vipul Khetarpaul, MD
        • Contact:
          • Kelly Koogler
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Recruiting
        • Atlantic Medical Imaging
        • Principal Investigator:
          • Nicholas Petruzzi
        • Contact:
          • Melisa Rivera
          • Phone Number: 3571 856-362-6056
        • Sub-Investigator:
          • Micah Watts
      • Marlton, New Jersey, United States, 08053
        • Recruiting
        • Virtua Health
        • Contact:
        • Principal Investigator:
          • Luai Tabaza
        • Sub-Investigator:
          • Anthony Smeglin, MD
    • New York
      • New Hyde Park, New York, United States, 11042
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Medical Center
        • Contact:
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Miami Valley Hospital
        • Contact:
        • Principal Investigator:
          • Sagger Mawri
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Sciences University
        • Contact:
        • Principal Investigator:
          • Rhusheet Patel
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Active, not recruiting
        • Penn Presbyterian Medical Center
      • Philadelphia, Pennsylvania, United States, 19141
        • Recruiting
        • Jefferson Einstein
        • Contact:
        • Principal Investigator:
          • Sahil Banka
    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Recruiting
        • Brown Health
        • Principal Investigator:
          • Peter Soukas, MD
        • Contact:
          • Bailey Nevins
          • Phone Number: 401-793-4105
    • South Carolina
      • Greenville, South Carolina, United States, 29615
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora St. Luke's
        • Contact:
          • Reva Matz
        • Principal Investigator:
          • Mark Mewissen, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of subjects with claudication or ischemic rest pain, with de novo or restenotic lesions in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects
The study population will consist of subjects with claudication or ischemic rest pain, with de novo or restenotic lesions in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae.
Device: Peripheral balloon angioplasty
Serration balloon angioplasty of iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Peri-procedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Peri-procedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cagent Vascular LLC

Collaborators

Julius Clinical
Yale Cardiovascular Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP-0696

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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