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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P240023 / PAS001 |
| Date Original Protocol Accepted |
02/12/2025
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| Date Current Protocol Accepted |
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| Study Name |
Completion of WAVE Study
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| Device Name |
WRAPSODY® Cell-Impermeable Endoprosthesis
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| Clinical Trial Number(s) |
NCT03644017 NCT04540302 NCT05062291
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study is a prospective, randomized (AVF cohort only), controlled, multicenter study comparing the Merit WRAPSODY Endovascular Stent Graft to Percutaneous Transluminal Angioplasty for treatment of venous outflow circuit stenosis or occlusion in hemodialysis patients.
The objective of this study is to demonstrate the long-term safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit, including:
a) AVF Peripheral - the peripheral veins of subjects with an arteriovenous (AV) fistula, and
b) AVG Peripheral – at the venous anastomosis of subjects with a synthetic arteriovenous graft access
Cohort (a) will be compared to PTA. Cohort (b) will be compared to performance goals.
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| Study Population |
The study comprises two (2) independent cohorts: 1) Subjects with AVF for hemodialysis who have stenosis or occlusion of the peripheral venous outflow circuit, including the cephalic arch; and 2) subjects with AVG for hemodialysis who have stenosis or occlusion at the graft-vein anastomosis or juxta-anastomosis.
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| Sample Size |
Number of subjects: 246 AVF peripheral subjects; 112 AVG Anastomosis Subjects; 16 Central Cohort
Number of sites: 43 centers; 10 international
Sites location: United States, United Kingdom, and Brazil
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| Key Study Endpoints |
Two primary endpoints are proposed:
Primary Safety: Proportion of subjects without any localized or systemic safety events through 30 days that affect the access or venous outflow circuit and result in reintervention, hospitalization, or death
Primary Effectiveness: Target Lesion Primary Patency (TLPP) at 6 months
Secondary:
Key secondary endpoints include:
TLPP at months 12 and 24
Access Circuit Primary Patency (ACPP) at months 6, 12, and 24
Rates of procedure- and device- related adverse events
Rate of device observations and potential malfunctions or failures
Number of reinterventions at months 6, 12, and 24 months
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| Follow-up Visits and Length of Follow-up |
After the index procedure on Day 0, subjects shall be evaluated within the clinic at 30 days, then at months 6, 12 and 24. Telephone follow-up shall be completed at months 3, 9 and 18.
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