Serranator POINT FORCE Registry

Recruiting now

Conditions studied: Peripheral Artery Disease (PAD), Dysfunctional AV Fistula, Dysfunctional AV Graft

In brief

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.

Key facts

Study ID

NCT06687590

Run by

Cagent Vascular LLC

People needed

500

Starts

2025-01-22

Expected to finish

2026-08-31

Last updated by the study team

2026-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Aurora St. Luke's — Milwaukee, Wisconsin, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Hartford HealthCare — Hartford, Connecticut, United States (enrolling)
• MedStar Washington Hospital / MedStar Montgomery — Washington D.C., District of Columbia, United States (enrolling)
• Manatee Memorial — Bradenton, Florida, United States (enrolling)
• Radiology and Imaging Specialists — Lakeland, Florida, United States (enrolling)
• Henry Ford Health — Detroit, Michigan, United States (enrolling)
• Barnes Jewish — St Louis, Missouri, United States (enrolling)
• Atlantic Medical Imaging — Brick, New Jersey, United States (enrolling)
• Virtua Health — Marlton, New Jersey, United States (enrolling)
• Northwell — New Hyde Park, New York, United States (enrolling)
• Ohio State University Medical Center — Columbus, Ohio, United States (enrolling)
• Miami Valley Hospital — Dayton, Ohio, United States (enrolling)
• Oregon Health & Sciences University — Portland, Oregon, United States (enrolling)
• HonorHealth — Scottsdale, Arizona, United States (enrolling)
• Jefferson Einstein — Philadelphia, Pennsylvania, United States (enrolling)
• Brown Health — Providence, Rhode Island, United States (enrolling)
• Prisma Health — Greenville, South Carolina, United States (enrolling)
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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