Actively Recruiting

Age: 18Years +
All Genders
NCT06687590

Serranator POINT FORCE Registry

Led by Cagent Vascular LLC · Updated on 2026-05-07

500

Participants Needed

19

Research Sites

83 weeks

Total Duration

On this page

Sponsors

C

Cagent Vascular LLC

Lead Sponsor

Y

Yale Cardiovascular Research Group

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Serranator POINT FORCE Registry

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Intended treatment with Serranator4 for new or recurring lesions in specified arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae
  • Presenting with claudication or critical limb-threatening ischemia by Rutherford Clinical Category 3, 4, 5, or 6 in the target limb
  • Age over 18 years
  • Provided informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Any medical condition making treatment with Serranator4 inappropriate as per Instructions for Use or investigator judgment
  • Currently enrolled in other investigational interventional studies that interfere with study endpoints

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 19 locations

1

HonorHealth

Scottsdale, Arizona, United States, 85251

Actively Recruiting

2

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

3

Hartford HealthCare

Hartford, Connecticut, United States, 06102

Actively Recruiting

4

MedStar Washington Hospital / MedStar Montgomery

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

5

Manatee Memorial

Bradenton, Florida, United States, 34208

Actively Recruiting

6

Radiology and Imaging Specialists

Lakeland, Florida, United States, 33801

Actively Recruiting

7

Henry Ford Health

Detroit, Michigan, United States, 48202

Actively Recruiting

8

Barnes Jewish

St Louis, Missouri, United States, 63141

Actively Recruiting

9

Atlantic Medical Imaging

Brick, New Jersey, United States, 08724

Actively Recruiting

10

Virtua Health

Marlton, New Jersey, United States, 08053

Actively Recruiting

11

Northwell

New Hyde Park, New York, United States, 11042

Actively Recruiting

12

Ohio State University Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

13

Miami Valley Hospital

Dayton, Ohio, United States, 45409

Actively Recruiting

14

Oregon Health & Sciences University

Portland, Oregon, United States, 97239

Actively Recruiting

15

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States, 19104

Active, Not Recruiting

16

Jefferson Einstein

Philadelphia, Pennsylvania, United States, 19141

Actively Recruiting

17

Brown Health

Providence, Rhode Island, United States, 02912

Actively Recruiting

18

Prisma Health

Greenville, South Carolina, United States, 29615

Actively Recruiting

19

Aurora St. Luke's

Milwaukee, Wisconsin, United States, 53215

Actively Recruiting

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Research Team

A

Alexis Shewfelt

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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