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Serranator POINT FORCE Registry
Sponsor: Cagent Vascular LLC
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.
Official title: POst-Market ClINical Follow-up STudy oF the SerranatOR PTA Serration Balloon CathEter
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2025-01-22
Completion Date
2026-08-31
Last Updated
2026-05-07
Healthy Volunteers
No
Interventions
Peripheral 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