Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
Key facts
- Where
- Atlanta, Boston, Columbia, Decatur, Greenwood, Houston, Las Vegas, Long Beach, Memphis, Nashville, New Orleans, Roanoke és Sarasota, Egyesült ÁllamokSee the 13 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Forrás: NCT06516653: ki vehet részt
Where in Egyesült Államok
- Grady Memorial HospitalAtlanta, Egyesült ÁllamokTaking people
- Brigham and Women's HospitalBoston, Egyesült ÁllamokTaking people
- Fresenius Vascular Care ColumbiaColumbia, Egyesült ÁllamokTaking people
- Atlanta VA Medical CenterDecatur, Egyesült ÁllamokTaking people
- Greenwood Leflore HospitalGreenwood, Egyesült ÁllamokTaking people
- Houston Methodist HospitalHouston, Egyesült ÁllamokTaking people
- Azura Surgery Center Las VegasLas Vegas, Egyesült ÁllamokNo longer taking part
- Fresenius Vascular Care Long BeachLong Beach, Egyesült ÁllamokTaking people
- James E. Gardner MD, P.C.Memphis, Egyesült ÁllamokToborzás még nem indult
- Vanderbilt University Medical CenterNashville, Egyesült ÁllamokTaking people
- Ochsner Clinic FoundationNew Orleans, Egyesült ÁllamokTaking people
- Fairlawn Surgery CenterRoanoke, Egyesült ÁllamokTaking people
- Sarasota Memorial Health Care SystemSarasota, Egyesült ÁllamokTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Laminate Medical Technologies
- Trial code
- NCT06516653
- Record updated
- 2026. november 4.
- Original description
VasQ is an external support implant for arteriovenous fistulas created for dialysis access.Read full original descriptionShow less
Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.
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
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: Known central venous stenosis or obstruction on the side of surgery; Expected kidney transplant within 12 months of enrollment; 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); Planned subsequent fistula superficialization procedure; Known coagulation disorder; Known allergy to nitinol; Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ; Pre-existing stents or stent grafts in the access circuit; 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.