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Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.
Who can join
Ages 18 to 80 · All sexes
Full eligibility criteria
Inclusion Criteria: 1. 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. 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: 1. Index procedure being a revision surgery of an existing fistula. 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.
About the study
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
What is being tested
- VasQ (device)
- Arteriovenous fistula creation for dialysis vascular access (procedure)
Sponsor: Laminate Medical Technologies · Participants: 300 · Started: Jan 13, 2025
Contact the study team
- Galit Itzhaki · Phone: +972-3-6344246
Official record on ClinicalTrials.gov — NCT06516653
Locations in the U.S.
| California | Fresenius Vascular Care Long Beach, Long Beach |
| Florida | Sarasota Memorial Hospital, Sarasota |
| Georgia | Grady Memorial Hospital, Atlanta |
| Massachusetts | Brigham and Women's Hospital, Boston |
| Mississippi | Greenwood Leflore Hospital, Greenwood |
| South Carolina | Fresenius Vascular Care Columbia, Columbia |
| Texas | Houston Methodist Hospital, Houston |
| Virginia | Fairlawn Surgery Center, Roanoke |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.