Back to Trials
NCT06687590Recruiting

Serranator POINT FORCE Registry

Cagent Vascular LLC

Start Date

1/22/2025

Completion Date

8/31/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Peripheral balloon angioplasty

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Peripheral Artery Disease (PAD)Dysfunctional AV FistulaDysfunctional AV Graft

Locations

HonorHealth

Scottsdale, Arizona 85251

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

Hartford HealthCare

Hartford, Connecticut 06102

United States

MedStar Washington Hospital / MedStar Montgomery

Washington D.C., District of Columbia 20010

United States

Manatee Memorial

Bradenton, Florida 34208

United States

Radiology and Imaging Specialists

Lakeland, Florida 33801

United States

Henry Ford Health

Detroit, Michigan 48202

United States

Barnes Jewish

St Louis, Missouri 63141

United States

Atlantic Medical Imaging

Brick, New Jersey 08724

United States

Virtua Health

Marlton, New Jersey 08053

United States

Northwell

New Hyde Park, New York 11042

United States

Ohio State University Medical Center

Columbus, Ohio 43210

United States

Miami Valley Hospital

Dayton, Ohio 45409

United States

Oregon Health & Sciences University

Portland, Oregon 97239

United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania 19104

United States

Jefferson Einstein

Philadelphia, Pennsylvania 19141

United States

Brown Health

Providence, Rhode Island 02912

United States

Prisma Health

Greenville, South Carolina 29615

United States

Aurora St. Luke's

Milwaukee, Wisconsin 53215

United States