Purpose

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 fistula, influencing hemodynamics, minimizing turbulence and promote laminar flow. All patients will be implanted with the VasQ device and will be followed up for a duration of 24 months.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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. 2. Male and female participants. 3. Age 18-80 years. 4. Patients willing and able to attend follow up visits over a period of 24 months.

Exclusion Criteria

  1. Patients with the planned index procedure being a revision surgery of an existing fistula. 2. 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. 3. 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. 4. 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.) 5. Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ. 6. Patients with 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. 11. Known allergy to nitinol. 12. Life expectancy less than 30 months. 13. Patients expecting to undergo kidney transplant within 6 months of enrollment. 14. Women of child bearing age without documented current negative pregnancy test. 15. Inability to give consent and/or comply with the study follow up schedule.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VasQ device implantation
Main study cohort: Prospective, multi-center, single-arm, open label, enrolling patients referred to surgical creation of new brachiocephalic fistula (BCF). The VasQ will be applied to the AV fistula in all patients. The primary effectiveness endpoint for this trial will be measured at 6 months and compared to a performance goal (PG). Safety will compare descriptively between AE rates for Steal, Infection, Aneurysm and Seroma. Patients will be followed up for an additional 18 months for a total of 2 years. Additionally, this trial has several secondary endpoints. Supplementary study cohort: 15 patients will be prospectively enrolled which are referred to surgical creation of a new forearm arteriovenous fistula. VasQ will be applied to the AV fistula in all patients. Patients will be followed in the same manner as in the Main study cohort, however, the data will be reported separately and not be part of the analysis sets for the study primary and secondary endpoints.
  • Device: VasQ
    An external support device for AV fistula

More Details

Status
Completed
Sponsor
Laminate Medical Technologies

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.