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|
| General |
| Study Status |
Completed |
| 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 |
| Actual Number of Patients Enrolled |
142 subjects were consented
131 subjects had successful procedures completed
|
| Actual Number of Sites Enrolled |
Actual Number of Sites Enrolled 12 sites enrolled at least 1 subject
|
| Patient Followup Rate |
Follow-up Rate 131 subjects with completed successful procedure
1wk: 126/131 (96.2%)
4wk: 126/128 (98.4%)
3mo: 113/121 (93.4%)
6mo: 108/114 (94.7%)
12mo: 98/99 (99.0%)
At study completion, 32 subjects had exited the study early: 3 adverse event, 7 death, 11 investigator withdrew subject, 5 subject chose to exit, 2 kidney transplant, 2 peritoneal dialysis, 2 lost to follow-up
|
| Final Safety Findings |
Safety Results Subjects with any of the following through 12 months:
device-related events: 8/131 (6.1%)
procedure-related events: 18/131 (13.7%)
secondary procedure-related events: 11/131 (8.4%)
serious adverse events: 55/131 (42.0%)
Early occlusions (within 7 days of procedure):
2/131 (1.5%) subjects
|
| Final Effectiveness Findings |
Effectiveness Results Key safety findings (6 months | 12 months)
Cumulative patency: 99.1% | 99.1%
Primary patency: 64.1% | 54.1%
Assisted primary patency: 92.9% | 90.1%
Physiological maturation (site reported | Core Lab)
3 months: 56/113 (49.6%) | 52/113 (46.0%)
6 months: 64/108 (59.3%) | 57/108 (52.8%)
12 months: 51/98 (52.0%) | 38/98 (38.8%)
Functional cannulation success rate KM estimate
6 months: 49.3% (58)
12 months: 75.7% (85)
|
| Study Strengths and Weaknesses |
Study Strengths and Weaknesses Strengths: Study events were adjudicated by an external clinical events committee (CEC) and duplex ultrasound images were evaluated by an external Core lab; study collected data on real-world use of the device.
Weaknesses: This was a non-randomized, non-blinded clinical trial with inherent biases. The study demographics over-represent White subjects compared to the End-Stage Kidney Disease population.
|
| Recommendations for Labeling Changes |
Recommendations for Labeling Changes No labeling changes recommended; the manufacturer has indicated the device will no longer be marketed.
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