|
|
| General |
| Study Status |
Ongoing |
| 522 Number / Requirement Number |
PS230004 / PSS001 |
| Date Original Plan Accepted |
06/05/2024
|
| Study Name |
VasQ Postmarket Surveillance Study
|
| Device Name |
Vasq
|
| Root Document Number |
DEN220026
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study
arms:
. Treatment arm: End to side fistula supported with VasQ
. Control: Standard of care end to side fistula
The objective is to address the 522 Study Questions listed in the 522 order and above in Section II.C.
|
| Study Population |
Patients who are candidates for the creation of a new end-to-side surgical arteriovenous fistula (AVF), per VasQ IFU and investigator clinical
judgment.
|
| Sample Size |
Number of subjects: 300 (1:1 randomization between treatment and control arm)
Assumptions for sample size estimation: Expected rate of patients with functional fistula at 20, 50, 100, 150, 180 days
Note: The sample size for this study was determined to be clinically meaningful and was specified in the appeal decision letter.
Number of sites: 18
Sites location: Not yet available
|
| Key Study Endpoints |
Safety Endpoints
Primary: Comparable rate of access related complications (including major reintervention and cannulation related complications)
Effectiveness Endpoints
Primary: Time to clinically functional AVF post fistula placement, up to 6 months post fistula placement
. Time to functional patency is defined as the time, in days, to the first day of a 28-day period in which the study fistula was able to
be cannulated with two dialysis needles for at least 75% of dialysis sessions to achieve the prescribed dialysis. (Beathard et al Clin J
Am Soc Nephrol 13: 501–512, 2018)
. Primary efficacy analysis set – Patients who are already on dialysis at the time of fistula placement.
Secondary:
1. Access primary patency
2. Access assisted primary patency
3. Access cumulative (secondary) patency
4. Reinterventions rate
5. Post-intervention cumulative patency
6. Central Venous Catheter (CVC) dwell time
7. CVC removal rate
8. Time to clinically functional AVF, up to 12 months post procedure
9. Time to unassisted clinically functional AVF up to 6 months and
12 months follow up
|
| Follow-up Visits and Length of Follow-up |
Length of Follow-up: 12 months
Follow-up Visits: 1, 3, 6, and 12 months
|
