Actively Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
Led by Laminate Medical Technologies · Updated on 2025-10-30
300
Participants Needed
7
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms: * Treatment arm: End to side fistula supported with VasQ * Control: Standard of care end to side fistula
CONDITIONS
Official 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 a new radiocephalic or brachiocephalic end-to-side surgical arteriovenous fistula for dialysis access and consent to participate.
- Male and non-pregnant female participants.
- Age between 18 and 80 years.
- Willing and able to attend follow-up visits for 12 months.
You will not qualify if you...
- Revision surgery of an existing fistula as the index procedure.
- Target vein on the surgery side having 50% or more stenosis diagnosed by ultrasound.
- Unusual anatomy or vessel size that prevents proper fit of the VasQ device.
- Known central venous stenosis or blockage on the surgery side.
- Pre-existing stents or stent grafts in the dialysis access circuit.
- Planned fistula superficialization procedure after surgery.
- Known blood clotting disorder.
- Known allergy to nitinol.
- Expected kidney transplant within 12 months of enrollment.
- Inability to give consent or comply with follow-up visits.
- Life expectancy too short to complete 12 months of study follow-up.
- Participation in another interventional study that could interfere with results.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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