Trials / Completed
CompletedNCT04484220
Ellipsys Vascular Access System Post Market Surveillance (PS) Study
Ellipsys Vascular Access System Post Market Surveillance (PS) Study PS200001 Reference DEN170004
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 142 (actual)
- Sponsor
- Medtronic Endovascular · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The proposed clinical study is a prospective, non-randomized, multi-center, single-arm, observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in subjects eligible for arteriovenous (AV) fistula.
Detailed description
The primary objective of this post-market surveillance study is to support the short-term safety of the device and procedure and further assess long-term safety and effectiveness in subjects treated by newly trained providers of the Ellipsys Vascular Access System in the creation of a native AV fistula via percutaneous access in subjects who are on hemodialysis and are medically indicated for the creation of an upper limb anastomosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ellipsys Vascular Access System | The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis. |
Timeline
- Start date
- 2021-04-13
- Primary completion
- 2025-03-31
- Completion
- 2025-03-31
- First posted
- 2020-07-23
- Last updated
- 2025-04-16
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04484220. Inclusion in this directory is not an endorsement.