End Stage Renal Disease
Conditions
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 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
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 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?
Interventions
DEVICEVasQ
External support implant for the arteriovenous fistula
PROCEDUREArteriovenous fistula creation for dialysis vascular access
End to side fistula creation in the arm for dialysis vascular access
Sponsors
Laminate Medical Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fistula functional success | 6 months | The time, in days, to the first day of a 28-day period in which the study fistula was able to be cannulated with two dialysis needles for at least 75% of dialysis sessions to achieve the prescribed dialysis |
Countries
United States
Contacts
CONTACTGalit Itzhaki
PRINCIPAL_INVESTIGATORJohn F Lucas III, MD FACS FSVS
Greenwood Leflore Hospital
Outcome results
None listed