Trials / Completed
CompletedNCT03246984
VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
A Post Market Surveillance Multi-center Prospective Study to Evaluate the Safety and Efficacy of the VasQ External Support for Arteriovenous Fistula
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Laminate Medical Technologies · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up period in this study will be for a duration of 12 months, with follow up visits scheduled at 1, 3, 6, 9, and 12 months.
Conditions
- Arterio-Venous Fistula
- Kidney Failure, Chronic
- Kidney Diseases
- Renal Failure Chronic
- ESRD
- Arteriovenous Fistula Thrombosis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VasQ | VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation. |
Timeline
- Start date
- 2017-09-07
- Primary completion
- 2021-01-11
- Completion
- 2021-01-11
- First posted
- 2017-08-11
- Last updated
- 2024-01-31
Locations
11 sites across 4 countries: France, Germany, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT03246984. Inclusion in this directory is not an endorsement.