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 |
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.
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
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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