RecruitingNCT06687590

Serranator POINT FORCE Registry

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

Sponsor

Cagent Vascular LLC

Enrollment

500 participants

Start Date

Jan 22, 2025

Study Type

OBSERVATIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Peripheral balloon angioplasty for people with dysfunctional av fistula, dysfunctional av graft, and other related conditions. The study is currently recruiting participants at 19 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPeripheral balloon angioplasty

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

Locations(19)

HonorHealth

Scottsdale, Arizona, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Hartford HealthCare

Hartford, Connecticut, United States

MedStar Washington Hospital / MedStar Montgomery

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

Manatee Memorial

Bradenton, Florida, United States

Radiology and Imaging Specialists

Lakeland, Florida, United States

Henry Ford Health

Detroit, Michigan, United States

Barnes Jewish

St Louis, Missouri, United States

Atlantic Medical Imaging

Brick, New Jersey, United States

Virtua Health

Marlton, New Jersey, United States

Northwell

New Hyde Park, New York, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Miami Valley Hospital

Dayton, Ohio, United States

Oregon Health & Sciences University

Portland, Oregon, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Jefferson Einstein

Philadelphia, Pennsylvania, United States

Brown Health

Providence, Rhode Island, United States

Prisma Health

Greenville, South Carolina, United States

Aurora St. Luke's

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06687590

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