|
|
| General |
| Study Status |
Delayed |
| 522 Number / Requirement Number |
PS180002 / PSS001 |
| Date Original Plan Accepted |
11/06/2020
|
| Date Current Plan Accepted |
02/27/2024
|
| Study Name |
WavelinQ EndoAVF
|
| Device Name |
Wavelinq endoavf system
|
| Root Document Number |
DEN160006
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a global, prospective, multi-center, non-randomized, single-arm, post-market study for endoAVF creation in a real world setting for patients who require vascular access for hemodialysis. Follow-up for all treated subjects will be performed at discharge, 2-weeks, 6-weeks, 3-, 6-, 12-, 18- and 24- months post index procedure.
|
| Study Population |
The WavelinQ™ EndoAVF System is used to create an endovascular AVF (endoAVF) in adult patients with established, non-reversible kidney failure requiring hemodialysis, with a life expectancy sufficient to allow for completion of all study procedures. This study will enroll subjects who meet the inclusion and exclusion criteria as determined by the treating investigators medical judgment.
The study will enroll subjects who are already receiving dialysis at the time of screening, regardless of access type (Central Venous Catheter (CVC), AV Fistula (AVF), AV Graft (AVG)). In addition, the study will make all reasonable efforts to treat a population that consists of at least 30% African Americans and have no single study site constitute more than 15% of the total study population.
|
| Sample Size |
220
|
| Key Study Endpoints |
Two primary effectiveness endpoints will be evaluated independently: the percentage of subjects with functional cannulation success through 6-months and primary patency through 6-months.
The primary safety endpoint is freedom from device-related or procedure-related serious adverse events (SAE) through 30 days.
|
| Follow-up Visits and Length of Follow-up |
24 months
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
17
|
| Actual Number of Sites Enrolled |
4
|
| Patient Followup Rate |
N/A
|
| Final Safety Findings |
N/A
|
| Final Effectiveness Findings |
N/A
|
