Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
Recruiting · NCT06516653 · Interventional (participants receive a specific treatment) · Lead sponsor: Laminate Medical Technologies
View the official record on ClinicalTrials.gov →Interventions studied
Arteriovenous fistula creation for dialysis vascular accessVasQ
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
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
9 locations listed across 9 US states.
- Fresenius Vascular Care Long Beach - Long Beach, California, United States
- Sarasota Memorial Hospital - Sarasota, Florida, United States
- Grady Memorial Hospital - Atlanta, Georgia, 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
- Houston Methodist Hospital - Houston, Texas, United States
- Fairlawn Surgery Center - Roanoke, Virginia, United States