Serranator POINT FORCE Registry
POINT FORCE
POst-Market ClINical Follow-up STudy oF the SerranatOR PTA Serration Balloon CathEter
1 other identifier
observational
500
1 country
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2025
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2024
CompletedFirst Posted
Study publicly available on registry
November 13, 2024
CompletedStudy Start
First participant enrolled
January 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
May 7, 2026
May 1, 2026
1.4 years
November 12, 2024
May 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Performance Endpoint
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.
Peri-procedural
Secondary Outcomes (1)
Safety Endpoint
Peri-procedural
Study Arms (1)
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.
Interventions
Serration balloon angioplasty of iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistula
Eligibility Criteria
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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cagent Vascular LLClead
- Yale Cardiovascular Research Groupcollaborator
- Julius Clinicalcollaborator
Study Sites (19)
HonorHealth
Scottsdale, Arizona, 85251, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Hartford HealthCare
Hartford, Connecticut, 06102, United States
MedStar Washington Hospital / MedStar Montgomery
Washington D.C., District of Columbia, 20010, United States
Manatee Memorial
Bradenton, Florida, 34208, United States
Radiology and Imaging Specialists
Lakeland, Florida, 33801, United States
Henry Ford Health
Detroit, Michigan, 48202, United States
Barnes Jewish
St Louis, Missouri, 63141, United States
Atlantic Medical Imaging
Brick, New Jersey, 08724, United States
Virtua Health
Marlton, New Jersey, 08053, United States
Northwell
New Hyde Park, New York, 11042, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Oregon Health & Sciences University
Portland, Oregon, 97239, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Jefferson Einstein
Philadelphia, Pennsylvania, 19141, United States
Brown Health
Providence, Rhode Island, 02912, United States
Prisma Health
Greenville, South Carolina, 29615, United States
Aurora St. Luke's
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2024
First Posted
November 13, 2024
Study Start
January 22, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
May 7, 2026
Record last verified: 2026-05