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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P240023 / PAS001 |
| Date Original Protocol Accepted |
02/12/2025
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| Date Current Protocol Accepted |
02/12/2025
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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 yrs < 22 yrs,
Adult: At least 22 yrs
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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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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
AVF Cohort (Randomized 1:1 WRAPSODY to PTA): 246
AVG Cohort (WRAPSODY only): 112
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| Actual Number of Sites Enrolled |
43 sites; 33 US sites; 4 Brazilian sites; 1 Canadian site; 5 UK sites
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| Patient Follow-up Rate |
Completed the study:
Overall: 215/374 (57.5%)
AVF: 151/246 (61.4%)
AVG: 54/112 (48.2%)
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| Final Safety Findings |
AVF Cohort (WRAPSODY | PTA):
Primary Safety:
30-Day Safety*: 96.6% (115/119) | 95.0% (115/121)
*defined as freedom from localized or systemic safety events that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis)
Secondary Safety:
Rates of Procedure-Related Adverse Events
6 Months: 6.1% (7/115) | 17.4% (20/115)
12 Months: 6.6% (7/106) | 21.2% (21/99)
24 Months: 8.4% (7/83) | 26.9% (21/78)
Rates of Device-Related Adverse Events
6 Months: 2.6% (3/114) | 8.0% (9/113)
12 Months: 2.9% (3/105) | 9.4% (9/96)
24 Months: 3.7% (3/81) | 12.3% (9/73)
Rate of device observations and potential malfunctions or failures: 2.5% (3/122) | N/A
AVG Cohort (WRAPSODY only)
Primary Safety:
30-Day Safety*: 95.4% (104/109)
*defined as freedom from localized or systemic safety events that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis)
Secondary Safety:
Rates of Procedure-Related Adverse Events:
6 Months: 14.7% (14/95)
12 Months: 17.5% (14/80)
24 Months: 23.3% (14/60)
Rates of Device-Related Adverse Events:
6 Months: 8.4% (8/95)
12 Months: 10.1% (8/79)
24 Months: 13.8% (8/58)
Rate of device observations and potential malfunctions or failures: 0.0% (0/112)
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| Final Effect Findings |
AVF Cohort (WRAPSODY | PTA):
Primary Effectiveness:
Target Lesion Primary Patency (TLPP) at 6 Months: 89.6% (103/115) | 62.3% (71/114)
Secondary Effectiveness:
TLPP:
12 Months: 70.4% (76/108) | 38.5% (40/104)
24 Months: 45.2% (42/93) | 22.3% (21/94)
Access Circuit Primary Patency (ACPP):
6 Months: 72.2% (83/115) | 57.0% (65/114)
12 Months: 56.4% (62/110) | 31.1% (33/106)
24 Months: 27.3% (27/99) | 15.2% (15/99)
Mean number of target lesion reinterventions (total number):
6 Months: 0.18 (115) | 0.47 (114)
12 Months: 0.49 (108) | 1.08 (104)
24 Months: 1.26 (93) | 1. 80 (94)
AVG Cohort (WRAPSODY only)
Primary Effectiveness:
Target Lesion Primary Patency (TLPP) at 6 Months: 81.4% (79/97)
Secondary Effectiveness:
TLPP:
12 Months: 58.0% (51/88)
24 Months: 33.8% (26/77)
Access Circuit Primary Patency (ACPP):
6 Months: 68.0% (68/100)
12 Months: 33.7% (31/92)
24 Months: 19.8% (17/86)
Mean number of target lesion reinterventions (total number):
6 Months: 0.21 (97)
12 Months: 0.66 (88)
24 Months: 1.40 (77)
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| Study Strengths & Weaknesses |
Strengths: This was a prospective, consecutively enrolling study. Imaging was analyzed by a Core Lab, and a Clinical Events Committee adjudicated procedure- and device-relatedness of events. Weaknesses: The AVG Cohort of this study is a non-randomized study with inherent biases. Follow-up was achieved in 57.5% of subjects at 24 months.
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| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the long-term results of the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study results (e.g., final endpoint results, follow-up rates, strengths and limitations of the PAS).
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