VasQ External Support for Arteriovenous Fistula



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Cardiology, Hospital, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Nephrology / Urology, Other
Healthy:No
Age Range:18 - 80
Updated:4/22/2018
Start Date:November 29, 2017
End Date:November 2020
Contact:Binyamin Mittelman, M.Sc.
Email:Binyamin@laminatemedical.com
Phone:+1-617-943-8234

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A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula

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.


Inclusion Criteria:

- 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.

- Male and female participants.

- Age 18-80 years.

- Patients willing and able to attend follow up visits over a period of 24 months.

Exclusion Criteria:

- Patients with the planned index procedure being a revision surgery of an existing
fistula.

- Target arteries smaller than 3 mm in diameter.

- Target vein smaller than 3 mm or larger than 6 mm in diameter.

- Significantly stenotic target vein on the side of surgery.

- Patients with central venous stenosis or obstruction on the side of surgery.

- Depth of vein greater than 8 mm on side of surgery.

- Known coagulation disorder.

- 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.
We found this trial at
12
sites
Charlotte, North Carolina 28210
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Boston, Massachusetts 02118
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Cleveland, Ohio 44195
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Greenville, South Carolina 29615
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New York, New York 10467
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