Trials / Completed
CompletedNCT03242343
VasQ External Support for Arteriovenous Fistula
A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 144 (actual)
- Sponsor
- Laminate Medical Technologies · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | VasQ | An external support device for AV fistula |
Timeline
- Start date
- 2017-11-29
- Primary completion
- 2020-10-08
- Completion
- 2022-04-03
- First posted
- 2017-08-08
- Last updated
- 2023-10-06
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03242343. Inclusion in this directory is not an endorsement.