VasQ External Support for Arteriovenous Fistula

Completed · Not applicable

Conditions studied: Arterio-Venous Fistula, ESRD, Steal Syndrome, Aneurysm, Renal Failure, Renal Disease, Diabetes Mellitus, Kidney Failure

In brief

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.

Key facts

Study ID: NCT03242343
Run by: Laminate Medical Technologies
People needed: 144
Starts: 2017-11-29
Expected to finish: 2022-04-03
Last updated by the study team: 2026-05-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Grandview Medical Center — Birmingham, Alabama, United States
Arizona Kidney Disease & Hypertension Center — Phoenix, Arizona, United States
Saint Francis Medical Center — Peoria, Illinois, United States
Lutheran Medical Group/Indiana Ohio Heart — Fort Wayne, Indiana, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
Boston Medical Center — Boston, Massachusetts, United States
University of Michigan — Ann Arbor, Michigan, United States
Albany Medical College — Albany, New York, United States
Montefiore Medical Center — New York, New York, United States
Charlotte PA — Charlotte, North Carolina, United States
Duke University Medical Center — Durham, North Carolina, United States
Ohio State University Wexner Meidcal Center — Columbus, Ohio, United States
Greenville Health System — Greenville, South Carolina, United States
Cardiothoracic and Vascular Surgeons, P.A. — Austin, Texas, United States
Methodist DeBakey Heart and Vascular Center,The Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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