VasQ External Support for Arteriovenous Fistula
NCT03242343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2023-10-06
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 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
- Arterio-Venous Fistula
- ESRD
- Steal Syndrome
- Aneurysm
- Renal Failure
- Renal Disease
- Diabetes Mellitus
- Kidney Failure
Interventions
- DEVICE
-
VasQ
An external support device for AV fistula
Sponsors & Collaborators
-
Laminate Medical Technologies
lead INDUSTRY
Principal Investigators
-
Noam Zilberman · Laminate Medical Technologies Ltd.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-29
- Primary Completion
- 2020-10-08
- Completion
- 2022-04-03
- FDA Device
- Yes
Countries
- United States
Study Locations
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