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Clinical Trials in the USA / NCT06687590
Recruiting Observational

Serranator POINT FORCE Registry

NCT06687590 · tracked via the Priya Life Science USA tracker
Sponsor
Cagent Vascular LLC
Phase
Observational
Started
2025-01-22
Last updated
2026-05-07

Condition(s) studied

Peripheral Artery Disease (PAD)Dysfunctional AV FistulaDysfunctional AV Graft

Investigational drug(s) / intervention(s)

Peripheral balloon angioplasty

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Performance Endpoint — 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.

Trial sites (19)

FacilityCityRegionStatus
HonorHealth Scottsdale Arizona Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
Hartford HealthCare Hartford Connecticut Recruiting
MedStar Washington Hospital / MedStar Montgomery Washington D.C. District of Columbia Recruiting
Manatee Memorial Bradenton Florida Recruiting
Radiology and Imaging Specialists Lakeland Florida Recruiting
Henry Ford Health Detroit Michigan Recruiting
Barnes Jewish St Louis Missouri Recruiting
Atlantic Medical Imaging Brick New Jersey Recruiting
Virtua Health Marlton New Jersey Recruiting
Northwell New Hyde Park New York Recruiting
Ohio State University Medical Center Columbus Ohio Recruiting
Miami Valley Hospital Dayton Ohio Recruiting
Oregon Health & Sciences University Portland Oregon Recruiting
Penn Presbyterian Medical Center Philadelphia Pennsylvania Active Not Recruiting
Jefferson Einstein Philadelphia Pennsylvania Recruiting
Brown Health Providence Rhode Island Recruiting
Prisma Health Greenville South Carolina Recruiting
Aurora St. Luke's Milwaukee Wisconsin Recruiting

More Cagent Vascular LLC trials in the USA

Serrantor OCT Study Recruiting

Other trials for the same condition

Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease Recruiting
The Chocolate Touch Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06687590 on ClinicalTrials.gov ↗ ← All trials in the USA