Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
NCT ID: NCT06516653
Last Updated: 2025-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2025-01-13
2028-05-31
Brief Summary
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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
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Detailed Description
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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
Duration The primary endpoint is defined at 6 month post index procedure of fistula creation. Patients will be further followed up to 12 months post index procedure.
Main study question What is the magnitude of benefit of the VasQ device with regard to time to achieving a clinically functional AVF as compared to a comparable contemporary standard of care cohort?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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End to side fistula supported with VasQ
Patients receiving an end to side arteriovenous fistula, supported by VasQ, for fistula access
VasQ
External support implant for the arteriovenous fistula
Arteriovenous fistula creation for dialysis vascular access
End to side fistula creation in the arm for dialysis vascular access
Standard of care end to side fistula
Patients receiving an end to side arteriovenous fistula, for fistula access
Arteriovenous fistula creation for dialysis vascular access
End to side fistula creation in the arm for dialysis vascular access
Interventions
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VasQ
External support implant for the arteriovenous fistula
Arteriovenous fistula creation for dialysis vascular access
End to side fistula creation in the arm for dialysis vascular access
Eligibility Criteria
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Inclusion Criteria
2. Male and non-pregnant female participants.
3. Age 18-80 years
4. Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months.
Exclusion Criteria
2. 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)
3. Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
4. Known central venous stenosis or obstruction on the side of surgery.
5. Pre-existing stents or stent grafts in the access circuit.
6. Planned subsequent fistula superficialization procedure.
7. Known coagulation disorder.
8. Known allergy to nitinol.
9. Expected kidney transplant within 12 months of enrollment.
10. Inability to give consent and/or comply with the study follow up schedule.
11. Insufficient or borderline life expectancy to allow for completion of study procedures and follow-up (12 Months).
12. Participation in another interventional study that in the judgment of the investigator could confound study results.
18 Years
80 Years
ALL
No
Sponsors
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Laminate Medical Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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John F Lucas III, MD, FACS, FSVS
Role: PRINCIPAL_INVESTIGATOR
Greenwood Leflore Hospital
Locations
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Fresenius Vascular Care Long Beach
Long Beach, California, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Greenwood Leflore Hospital
Greenwood, Mississippi, United States
Azura Surgery Center Las Vegas
Las Vegas, Nevada, United States
Fresenius Vascular Care Columbia
Columbia, South Carolina, United States
Fairlawn Surgery Center
Roanoke, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CD0261
Identifier Type: -
Identifier Source: org_study_id
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