Taking people in United StatesNo phase
Serranator POINT FORCE Registry
Key facts
- Who runs it
- Cagent Vascular LLC
- Where
- Bradenton, Brick, Columbus, Dayton, Detroit, Greenville, Hartford, Lakeland, Los Angeles, Marlton, Milwaukee, New Hyde Park, Philadelphia, Portland, Providence, Scottsdale, St Louis, and Washington D.C., United StatesSee the 19 sites
- Trial code
- Status
- Recruiting
- People taking part
- 500 people, planned
- Started
- 22 Jan 2025
- Planned end
- 31 Aug 2026
- Type of study
- Observational
- Treatments tested
- Peripheral balloon angioplasty
- Record updated
- 7 May 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in United States
- Manatee MemorialBradenton, United StatesContact: Camila VeraTaking people
- Atlantic Medical ImagingBrick, United StatesContact: Melisa RiveraTaking people
- Ohio State University Medical CenterColumbus, United StatesContact: Subhashish DasTaking people
- Miami Valley HospitalDayton, United StatesContact: Heather BellTaking people
- Henry Ford HealthDetroit, United StatesContact: Renee BessTaking people
- Prisma HealthGreenville, United StatesContact: Nikita KasingerTaking people
- Hartford HealthcareHartford, United StatesContact: Candace JohnsonTaking people
- Radiology and Imaging SpecialistsLakeland, United StatesContact: Eve JohnsonTaking people
- Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Ayda AliyariTaking people
- Virtua HealthMarlton, United StatesContact: Jocelyn BordelonTaking people
- Aurora St. Luke'sMilwaukee, United StatesContact: Reva MatzTaking people
- NorthWellNew Hyde Park, United StatesContact: Victoria WaimiruTaking people
- Jefferson EinsteinPhiladelphia, United StatesContact: Vibha AhujaTaking people
- Penn Presbyterian Medical CenterPhiladelphia, United StatesContact: Alexis ShewfeltNo longer taking part
- Oregon Health Sciences UniversityPortland, United StatesContact: Amie LorischTaking people
- Brown HealthProvidence, United StatesContact: Bailey NevinsTaking people
- HonorHealthScottsdale, United StatesContact: Ayda AliyariTaking people
- Barnes JewishSt Louis, United StatesContact: Kelly KooglerTaking people
- MedStar Washington Hospital / MedStar MontgomeryWashington D.C., United StatesContact: Kassaye SesabaTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
The data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.
The group in the trial
- Subjects
The study population will consist of subjects with claudication or ischemic rest pain, with de novo or restenotic lesions in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae.
Treatment: Peripheral balloon angioplasty
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- POst-Market ClINical Follow-up STudy oF the SerranatOR PTA Serration Balloon CathEter
- Record updated
- 7 May 2026