Arterio-Venous Fistula, Arteriovenous Fistula Thrombosis, ESRD, Kidney Diseases, Kidney Failure, Chronic, Renal Failure Chronic
Conditions
Brief summary
This is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up period in this study will be for a duration of 12 months, with follow up visits scheduled at 1, 3, 6, 9, and 12 months.
Interventions
DEVICEVasQ
VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.
Sponsors
Laminate Medical Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients referred for creation of a new brachiocephalic or radiocephalic fistula who consent to take part in the study. 2. Age 18-80 years 3. Male and female participants 4. Patients willing and able to attend follow up visits over a period of 12 months
Exclusion criteria
1. Patients with the planned index procedure being a revision surgery of an existing fistula. 2. Target Brachial artery smaller than 2.5 mm or larger than 6 mm or Radial artery smaller than 2.5 mm or larger than 4 mm in outer diameter by preoperative ultrasound 3. Target vein outer diameter smaller than 2.5 mm by preoperative ultrasound 4. Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on pre-op ultrasound (scan should include the area between the planned anastomosis site and the Axillary vein) 5. Unusual anatomy or vessel dimensions (observed on pre-operative US or intraoperatively) and which preclude adequate fit of the VasQ. 6. Patients with prior central venous stenosis or obstruction on the side of surgery 7. Depth of vein greater than 8 mm (on ultrasound) on side of surgery 8. Known coagulation disorder 9. Congestive heart failure NYHA class ≥ 3 10. Prior steal on the side of surgery as evident from the patient's medical history 11. Known allergy to nitinol 12. Life expectancy less than 18 months 13. Patients expected to undergo kidney transplant within 6 months of enrollment 14. Women of child bearing potential without documented current negative pregnancy test 15. Inability to give consent and/or comply with the study follow up schedule
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency of AV fistula | 6 months post AVF creation | Freedom from any intervention designed to maintain or reestablish patency since device placement and demonstrate flow on Doppler US. 1 = Success = Intervention free access patency determined by Doppler ultrasound. 0 = Failure = Access occluded determined by Doppler ultrasound and/or underwent intervention |
Countries
France, Germany, Spain, United Kingdom
Outcome results
None listed