Status:
RECRUITING
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
Lead Sponsor:
Laminate Medical Technologies
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 enro...
Detailed Description
Structure 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 f...
Eligibility Criteria
Inclusion
- Patients who are candidates for the creation of a new radiocephalic or brachiocephalic end-to-side surgical AV fistula for dialysis access (per VasQ IFU and investigator clinical judgment) and consent to take part in the study.
- Male and non-pregnant female participants.
- Age 18-80 years
- Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months.
Exclusion
- Index procedure being a revision surgery of an existing fistula.
- Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the full length of the expected fistula outflow, starting at the planned anastomosis site)
- Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
- Known central venous stenosis or obstruction on the side of surgery.
- Pre-existing stents or stent grafts in the access circuit.
- Planned subsequent fistula superficialization procedure.
- Known coagulation disorder.
- Known allergy to nitinol.
- Expected kidney transplant within 12 months of enrollment.
- Inability to give consent and/or comply with the study follow up schedule.
- Insufficient or borderline life expectancy to allow for completion of study procedures and follow-up (12 Months).
- Participation in another interventional study that in the judgment of the investigator could confound study results.
Key Trial Info
Start Date :
January 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06516653
Start Date
January 13 2025
End Date
May 1 2028
Last Update
October 30 2025
Active Locations (7)
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1
Fresenius Vascular Care Long Beach
Long Beach, California, United States, 90706
2
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
Greenwood Leflore Hospital
Greenwood, Mississippi, United States, 38930