Actively Recruiting
Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use
Led by Laminate Medical Technologies · Updated on 2025-10-30
300
Participants Needed
7
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the VasQ external support implant designed for arteriovenous fistulas (AVF) used in dialysis access among patients with end stage renal disease. This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open-label trial enrolling 300 patients to compare the VasQ-supported AVF with the standard end-to-side fistula. The main question is to assess the benefit of VasQ in reducing the time to achieve a clinically functional AVF. Participants are randomly assigned to one of two groups: those receiving the end-to-side fistula supported by the VasQ device and those receiving the standard end-to-side fistula without VasQ. The primary endpoint is evaluated at 6 months after the fistula creation procedure, with follow-up continuing up to 12 months. The trial compares the performance of VasQ against current standard care in this surgical setting. During the study, patients attend follow-up visits over a 12-month period to monitor fistula function and related outcomes. Researchers will measure fistula functional success at 6 months as the primary outcome. The study involves clinical assessments and imaging as needed to evaluate the fistula and ensure proper function, with ongoing safety and performance monitoring throughout the trial duration.
CONDITIONS
Brief Title
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who are candidates for the creation of a new radiocephalic or brachiocephalic end-to-side surgical arteriovenous fistula for dialysis access
- Male and non-pregnant female participants
- Age between 18 and 80 years
- Patients willing and able to attend follow-up visits over 12 months
You will not qualify if you...
- Revision surgery of an existing fistula as the index procedure
- Target vein with significant stenosis (50% or more) on the side of surgery
- Unusual anatomy or vessel size that prevents VasQ fitting
- Known central venous stenosis or blockage on the surgery side
- Existing stents or stent grafts in the access circuit
- Planned fistula superficialization procedure
- Known blood clotting disorders
- Allergy to nitinol
- Expected kidney transplant within 12 months
- Inability to consent or comply with follow-up
- Life expectancy too short to complete study procedures and follow-up
- Participation in another interventional study that could affect results
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 - 1 day to 1 week
Participants undergo creation of an end to side arteriovenous fistula, with or without the VasQ external support implant, followed by immediate post-operative care.
1 surgical visit and approximately 1 post-operative visit
Duration - 6 months
Participants attend follow-up visits to monitor fistula function and recovery up to 6 months post-surgery.
Regular follow-up visits over 6 months
Duration - Additional 6 months after primary endpoint
Participants are followed to assess fistula functionality and safety outcomes up to 12 months after the surgery.
Scheduled visits up to 12 months post-surgery
Trial Site Locations
Total: 7 locations
1
Fresenius Vascular Care Long Beach
Long Beach, California, United States, 90706
Actively Recruiting
2
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Actively Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Greenwood Leflore Hospital
Greenwood, Mississippi, United States, 38930
Actively Recruiting
5
Azura Surgery Center Las Vegas
Las Vegas, Nevada, United States, 99128
Actively Recruiting
6
Fresenius Vascular Care Columbia
Columbia, South Carolina, United States, 29203
Actively Recruiting
7
Fairlawn Surgery Center
Roanoke, Virginia, United States, 24014
Actively Recruiting
Research Team
G
Galit Itzhaki
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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