Actively Recruiting
POst-Market ClINical Follow-up STudy oF the SerranatOR PTA Serration Balloon CathEter
Led by Cagent Vascular LLC · Updated on 2026-05-07
500
Participants Needed
19
Research Sites
8 weeks
Total Duration
On this page
Sponsors
C
Cagent Vascular LLC
Lead Sponsor
Y
Yale Cardiovascular Research Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are collecting observational data to evaluate the safety and performance of the Serranator4 balloon catheter in treating peripheral artery disease (PAD) and dysfunctional native or synthetic arteriovenous dialysis fistulae. This registry study observes patients treated under routine medical care to gather real-world evidence for clinical evaluation. Participants will undergo serration balloon angioplasty targeting arteries such as the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and pedal arteries, or dysfunctional dialysis fistulae. The study includes subjects with claudication or ischemic rest pain who have new or recurrent lesions in these areas. During the study, data on peri-procedural performance and safety endpoints will be collected while participants receive standard care. The researchers will monitor outcomes related to the device's use in real-world settings. Participation involves observation and data gathering without altering usual treatment, continuing until the study ends in August 2026.
CONDITIONS
Brief Title
Serranator POINT FORCE Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Intended treatment with Serranator4 for new or recurrent lesions in specific arteries or dysfunctional arteriovenous dialysis fistulae
- Presence of claudication or critical limb-threatening ischemia classified as Rutherford Clinical Category 3, 4, 5, or 6 in the target limb
- Age over 18 years
- Informed consent provided by the subject or legal representative
You will not qualify if you...
- Any medical condition making treatment with Serranator4 inappropriate as per instructions or investigator judgment
- Current enrollment in other investigational studies that could affect the study's endpoints
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Peri-procedural period
Participants undergo serration balloon angioplasty of affected arteries or dysfunctional arteriovenous dialysis fistulae using the Serranator device.
1 procedure visit
Duration - Up to several months post-procedure
Participants are observed following the angioplasty to assess performance and safety outcomes.
Follow-up visits as per routine clinical care
Trial Site Locations
Total: 19 locations
1
HonorHealth
Scottsdale, Arizona, United States, 85251
Actively Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
Hartford HealthCare
Hartford, Connecticut, United States, 06102
Actively Recruiting
4
MedStar Washington Hospital / MedStar Montgomery
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
5
Manatee Memorial
Bradenton, Florida, United States, 34208
Actively Recruiting
6
Radiology and Imaging Specialists
Lakeland, Florida, United States, 33801
Actively Recruiting
7
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
8
Barnes Jewish
St Louis, Missouri, United States, 63141
Actively Recruiting
9
Atlantic Medical Imaging
Brick, New Jersey, United States, 08724
Actively Recruiting
10
Virtua Health
Marlton, New Jersey, United States, 08053
Actively Recruiting
11
Northwell
New Hyde Park, New York, United States, 11042
Actively Recruiting
12
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
13
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Actively Recruiting
14
Oregon Health & Sciences University
Portland, Oregon, United States, 97239
Actively Recruiting
15
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Active, Not Recruiting
16
Jefferson Einstein
Philadelphia, Pennsylvania, United States, 19141
Actively Recruiting
17
Brown Health
Providence, Rhode Island, United States, 02912
Actively Recruiting
18
Prisma Health
Greenville, South Carolina, United States, 29615
Actively Recruiting
19
Aurora St. Luke's
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
Research Team
A
Alexis Shewfelt
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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