|
General |
Study Status |
Ongoing |
522 Number / Requirement Number |
PS200001 / PSS001 |
Date Original Plan Accepted |
05/29/2020
|
Date Current Plan Accepted |
12/29/2022
|
Study Name |
Ellipsys Vascular Access System Postmarket Study
|
Device Name |
Ellipsys vascular access system
|
Root Document Number |
DEN170004
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
Prospective, multi-center, single-arm, non-randomized, observational, post-market surveillance (PS) study. 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.
|
Study Population |
patients who are on hemodialysis and are medically indicated for the creation of upper limb anastomosis.
|
Sample Size |
Up to 134, over 14 US sites
|
Key Study Endpoints |
Primary Safety Endpoint: Early Occlusion, Study Related Serious Adverse Events through 12 months Primary Effectiveness Endpoint: Cumulative Patency through 12 months post-AVF creation
|
Follow-up Visits and Length of Follow-up |
12 months
|
Interim or Final Data Summary |
Interim Results |
Safety Results The study is collecting device-related, procedure-related, secondary-procedure related and all serious adverse events. Effectiveness Results Thus far: 6-month and 12-month cumulative patency (98.8%) and (98.8%) respectively.
Secondary procedures of the Ellipsys device thus far are comparable to device performance during IDE, and 5-year study.
|
Actual Number of Patients Enrolled |
142
|
Actual Number of Sites Enrolled |
13
|
Patient Followup Rate |
As of the data cutoff: 96.2% (126/131) of eligible subjects completed the Week 1 visit, 98.4% (126/128) completed the Week 4 visit, 91.2% (103/113) completed the Month 3 visit, 86.7% (78/90) completed the Month 6 visit and 97.5% (39/40) completed the Month 12 visit. A total of 70 subjects remain in follow-up.
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