Status:
COMPLETED
VasQ External Support for Arteriovenous Fistula
Lead Sponsor:
Laminate Medical Technologies
Conditions:
Arterio-Venous Fistula
ESRD
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fist...
Eligibility Criteria
Inclusion
- Main study cohort: Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study and which are not indicated for a more distal fistula per treatment guidelines.
- Supplementary study cohort: Patients referred for creation of a new forearm fistula who consent to take part in the study.
- Male and female participants.
- Age 18-80 years.
- Patients willing and able to attend follow up visits over a period of 24 months.
Exclusion
- Patients with the planned index procedure being a revision surgery of an existing fistula.
- Main study cohort: Target artery smaller than 2.5 mm or larger than 6 mm in inner diameter by preoperative ultrasound.
- Supplementary study cohort: Target artery smaller than 2 mm or larger than 4.1 mm in inner diameter by preoperative ultrasound.
- Main study cohort: Target vein smaller than 2.5 mm in inner diameter by preoperative ultrasound.
- Supplementary study cohort: Target vein smaller than 2 mm in inner diameter by preoperative ultrasound.
- Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the area between the planned anastomosis site and the Axillary vein.)
- Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
- Patients with central venous stenosis or obstruction on the side of surgery.
- Depth of vein greater than 8 mm (on ultrasound) on side of surgery.
- Known coagulation disorder.
- Congestive heart failure NYHA class ≥ 3.
- Prior steal on the side of surgery.
- Known allergy to nitinol.
- Life expectancy less than 30 months.
- Patients expecting to undergo kidney transplant within 6 months of enrollment.
- Women of child bearing age without documented current negative pregnancy test.
- Inability to give consent and/or comply with the study follow up schedule.
Key Trial Info
Start Date :
November 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2022
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT03242343
Start Date
November 29 2017
End Date
April 3 2022
Last Update
October 6 2023
Active Locations (15)
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1
Grandview Medical Center
Birmingham, Alabama, United States, 35243
2
Arizona Kidney Disease & Hypertension Center
Phoenix, Arizona, United States, 85012
3
Saint Francis Medical Center
Peoria, Illinois, United States, 61637
4
Lutheran Medical Group/Indiana Ohio Heart
Fort Wayne, Indiana, United States, 46804