Trial Outcomes & Findings for The Merit WRAPSODY AV Access Efficacy Study (WAVE) (NCT NCT04540302)
NCT ID: NCT04540302
Last Updated: 2026-06-10
Results Overview
Percentage of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis). Endovascular procedures performed to treat safety events after the index study procedure will be considered surgeries.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
357 participants
Primary outcome timeframe
30 days
Results posted on
2026-06-10
Participant Flow
Participant milestones
| Measure |
AVF Peripheral Study Treatment Group
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Overall Study
STARTED
|
122
|
123
|
112
|
|
Overall Study
COMPLETED
|
81
|
70
|
54
|
|
Overall Study
NOT COMPLETED
|
41
|
53
|
58
|
Reasons for withdrawal
| Measure |
AVF Peripheral Study Treatment Group
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Overall Study
Death
|
24
|
25
|
21
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
6
|
|
Overall Study
Early termination
|
11
|
24
|
28
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
3
|
|
Overall Study
Discharge Safety Follow-up Only
|
0
|
1
|
0
|
Baseline Characteristics
The Merit WRAPSODY AV Access Efficacy Study (WAVE)
Baseline characteristics by cohort
| Measure |
AVF Peripheral Study Treatment Group
n=122 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=123 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=112 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
Total
n=357 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 13.9 • n=9 Participants
|
60.1 years
STANDARD_DEVIATION 14.5 • n=27 Participants
|
64.1 years
STANDARD_DEVIATION 13.3 • n=267 Participants
|
61.8 years
STANDARD_DEVIATION 13.96 • n=265 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=9 Participants
|
54 Participants
n=27 Participants
|
61 Participants
n=267 Participants
|
167 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=9 Participants
|
69 Participants
n=27 Participants
|
51 Participants
n=267 Participants
|
190 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=9 Participants
|
37 Participants
n=27 Participants
|
28 Participants
n=267 Participants
|
106 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
81 Participants
n=9 Participants
|
86 Participants
n=27 Participants
|
83 Participants
n=267 Participants
|
250 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
12 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=9 Participants
|
51 Participants
n=27 Participants
|
69 Participants
n=267 Participants
|
167 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=9 Participants
|
62 Participants
n=27 Participants
|
34 Participants
n=267 Participants
|
161 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
13 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=9 Participants
|
0 participants
n=27 Participants
|
3 participants
n=267 Participants
|
4 participants
n=265 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=9 Participants
|
98 participants
n=27 Participants
|
85 participants
n=267 Participants
|
282 participants
n=265 Participants
|
|
Region of Enrollment
Brazil
|
17 participants
n=9 Participants
|
18 participants
n=27 Participants
|
17 participants
n=267 Participants
|
52 participants
n=265 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=9 Participants
|
7 participants
n=27 Participants
|
7 participants
n=267 Participants
|
19 participants
n=265 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Denominators include all subjects who have the indicated event or who have adequate follow-up
Percentage of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis). Endovascular procedures performed to treat safety events after the index study procedure will be considered surgeries.
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=119 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=121 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=109 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Subjects Without Any Localized or Systemic Safety Events (Primary Safety Endpoint)
|
115 Participants
|
115 Participants
|
104 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Denominators include all subjects who have the indicated event or who have adequate follow-up
Percentage of subjects with Target Lesion Primary Patency (TLPP) at 6 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=115 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=114 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=97 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Subjects With Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)
|
103 Participants
|
71 Participants
|
79 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Denominators include all subjects who have the indicated event or who have adequate follow-up
Percentage of subjects with Target Lesion Primary Patency (TLPP) at 12 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=108 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=104 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=88 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Subjects With Target Lesion Primary Patency
|
76 Participants
|
40 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Denominators include all subjects who have the indicated event or who have adequate follow-up
Percentage of subjects with Target Lesion Primary Patency (TLPP) at 24 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=93 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=94 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=77 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Subjects With Target Lesion Primary Patency
|
42 Participants
|
21 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Assisted Target Lesion Primary Patency (aTLPP) was analyzed using the Kaplan-Meier method. The reported percentages represent the Kaplan-Meier estimated probability of remaining free from loss of assisted target lesion primary patency at the specified time point. These estimates account for censoring and are not simple proportions of participants experiencing the event.
Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 6 months. aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up.
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=122 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=123 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=112 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
|
99.1 KM estimate (%)
|
99.1 KM estimate (%)
|
97.1 KM estimate (%)
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Assisted Target Lesion Primary Patency (aTLPP) was analyzed using the Kaplan-Meier method. The reported percentages represent the Kaplan-Meier estimated probability of remaining free from loss of assisted target lesion primary patency at the specified time point. These estimates account for censoring and are not simple proportions of participants experiencing the event.
Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 12 months. aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up.
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=122 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=123 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=112 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
|
99.1 KM estimate (%)
|
99.1 KM estimate (%)
|
93.4 KM estimate (%)
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Assisted Target Lesion Primary Patency (aTLPP) was analyzed using the Kaplan-Meier method. The reported percentages represent the Kaplan-Meier estimated probability of remaining free from loss of assisted target lesion primary patency at the specified time point. These estimates account for censoring and are not simple proportions of participants experiencing the event.
Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 24 months. aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up.
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=122 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=123 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=112 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
|
97.9 KM estimate (%)
|
99.1 KM estimate (%)
|
92.0 KM estimate (%)
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Denominators include all subjects who have the indicated event or who have adequate follow-up
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=115 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=114 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=100 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Subjects With Access Circuit Primary Patency (ACPP)
|
83 Participants
|
65 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Denominators include all subjects who have the indicated event or who have adequate follow-up
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=110 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=106 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=92 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Subjects With Access Circuit Primary Patency (ACPP)
|
62 Participants
|
33 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Denominators include all subjects who have the indicated event or who have adequate follow-up
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=99 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=99 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=86 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Subjects With Access Circuit Primary Patency (ACPP)
|
27 Participants
|
15 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Post-Procedure Secondary Patency was analyzed using the Kaplan-Meier method. The reported percentages represent the Kaplan-Meier estimated probability of remaining free from loss of Post-Procedure Secondary Patency at the specified time point. These estimates account for censoring and are not simple proportions of participants experiencing the event.
Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 6 months. Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up.
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=122 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=123 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=112 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Subjects With Post-Procedure Secondary Patency
|
100 KM estimate (%)
|
100 KM estimate (%)
|
95.1 KM estimate (%)
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Post-Procedure Secondary Patency was analyzed using the Kaplan-Meier method. The reported percentages represent the Kaplan-Meier estimated probability of remaining free from loss of Post-Procedure Secondary Patency at the specified time point. These estimates account for censoring and are not simple proportions of participants experiencing the event.
Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 12 months. Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up.
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=122 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=123 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=112 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Subjects With Post-Procedure Secondary Patency
|
100 KM estimate (%)
|
97.0 KM estimate (%)
|
88.4 KM estimate (%)
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Post-Procedure Secondary Patency was analyzed using the Kaplan-Meier method. The reported percentages represent the Kaplan-Meier estimated probability of remaining free from loss of Post-Procedure Secondary Patency at the specified time point. These estimates account for censoring and are not simple proportions of participants experiencing the event.
Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 24 months. Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up.
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=122 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=123 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=112 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Subjects With Post-Procedure Secondary Patency
|
97.3 KM estimate (%)
|
93.2 KM estimate (%)
|
80.2 KM estimate (%)
|
SECONDARY outcome
Timeframe: Index procedureRates of procedure-related adverse events involving the access circuit at index procedure
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=122 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=123 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=112 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Rates of Procedure-related Adverse Events Involving the Access Circuit
|
2 Participants
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Index procedureRates of device-related adverse events involving the access circuit at index procedure
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=122 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=123 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=112 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Rates of Device-related Adverse Events Involving the Access Circuit
|
0 Participants
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysRates of procedure-related adverse events involving the access circuit at 30 days
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=120 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=121 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=109 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Rates of Procedure-related Adverse Events Involving the Access Circuit
|
5 Participants
|
18 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 30 daysRates of device-related adverse events involving the access circuit at 30 days
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=119 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=121 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=109 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Rates of Device-related Adverse Events Involving the Access Circuit
|
1 Participants
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthsRates of procedure-related adverse events involving the access circuit at 6 months
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=115 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=115 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=95 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Rates of Procedure-related Adverse Events Involving the Access Circuit
|
7 Participants
|
20 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 6 monthsRates of device-related adverse events involving the access circuit at 6 months
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=114 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=113 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=95 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Rates of Device-related Adverse Events Involving the Access Circuit
|
3 Participants
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsRates of procedure-related adverse events involving the access circuit at 12 months
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=106 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=99 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=80 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Rates of Procedure-related Adverse Events Involving the Access Circuit
|
7 Participants
|
21 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsRates of device-related adverse events involving the access circuit at 12 months
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=105 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=96 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=79 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Rates of Device-related Adverse Events Involving the Access Circuit
|
3 Participants
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 24 MonthsRates of procedure-related adverse events involving the access circuit at 24 months
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=83 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=78 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=60 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Rates of Procedure-related Adverse Events Involving the Access Circuit
|
7 Participants
|
21 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 24 MonthsRates of device-related adverse events involving the access circuit at 24 months
Outcome measures
| Measure |
AVF Peripheral Study Treatment Group
n=81 Participants
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=73 Participants
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=58 Participants
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Rates of Device-related Adverse Events Involving the Access Circuit
|
3 Participants
|
9 Participants
|
8 Participants
|
Adverse Events
AVF Peripheral Study Treatment Group
Serious events: 75 serious events
Other events: 107 other events
Deaths: 24 deaths
AVF Peripheral Control Group
Serious events: 85 serious events
Other events: 121 other events
Deaths: 25 deaths
AVG Anastomosis
Serious events: 82 serious events
Other events: 104 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
AVF Peripheral Study Treatment Group
n=122 participants at risk
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=123 participants at risk
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=112 participants at risk
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Infections and infestations
Bacteremia or septicemia
|
4.1%
5/122 • Number of events 5 • 24 months
|
1.6%
2/123 • Number of events 2 • 24 months
|
7.1%
8/112 • Number of events 9 • 24 months
|
|
Vascular disorders
Bleeding complication
|
0.82%
1/122 • Number of events 1 • 24 months
|
4.1%
5/123 • Number of events 5 • 24 months
|
1.8%
2/112 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis or bronchiolitis
|
0.82%
1/122 • Number of events 1 • 24 months
|
0.00%
0/123 • 24 months
|
0.00%
0/112 • 24 months
|
|
Cardiac disorders
Cardiac arrest
|
9.0%
11/122 • Number of events 11 • 24 months
|
8.1%
10/123 • Number of events 10 • 24 months
|
2.7%
3/112 • Number of events 3 • 24 months
|
|
Cardiac disorders
Cardiac arrhythmia
|
0.82%
1/122 • Number of events 2 • 24 months
|
4.1%
5/123 • Number of events 6 • 24 months
|
2.7%
3/112 • Number of events 3 • 24 months
|
|
Cardiac disorders
Cardiogenic shock
|
0.82%
1/122 • Number of events 1 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
0.00%
0/112 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease (COPD)
|
0.82%
1/122 • Number of events 3 • 24 months
|
0.00%
0/123 • 24 months
|
0.00%
0/112 • 24 months
|
|
Cardiac disorders
Congestive Heart Failure (CHF)
|
1.6%
2/122 • Number of events 2 • 24 months
|
2.4%
3/123 • Number of events 3 • 24 months
|
1.8%
2/112 • Number of events 2 • 24 months
|
|
Cardiac disorders
Coronary Artery Disease (CAD)
|
1.6%
2/122 • Number of events 2 • 24 months
|
1.6%
2/123 • Number of events 3 • 24 months
|
0.89%
1/112 • Number of events 1 • 24 months
|
|
Cardiac disorders
Edema, significant
|
0.82%
1/122 • Number of events 1 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
0.89%
1/112 • Number of events 1 • 24 months
|
|
General disorders
Fever (> 38.3ºC/101ºF)
|
0.82%
1/122 • Number of events 1 • 24 months
|
0.00%
0/123 • 24 months
|
1.8%
2/112 • Number of events 3 • 24 months
|
|
Gastrointestinal disorders
Gastro-intestinal bleeding
|
2.5%
3/122 • Number of events 4 • 24 months
|
1.6%
2/123 • Number of events 3 • 24 months
|
5.4%
6/112 • Number of events 9 • 24 months
|
|
Injury, poisoning and procedural complications
Hemorrhage, with or without transfusion
|
0.00%
0/122 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
0.00%
0/112 • 24 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.5%
3/122 • Number of events 3 • 24 months
|
4.1%
5/123 • Number of events 5 • 24 months
|
0.00%
0/112 • 24 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/122 • 24 months
|
2.4%
3/123 • Number of events 3 • 24 months
|
3.6%
4/112 • Number of events 6 • 24 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.82%
1/122 • Number of events 1 • 24 months
|
0.00%
0/123 • 24 months
|
0.00%
0/112 • 24 months
|
|
Vascular disorders
Hypotension
|
4.9%
6/122 • Number of events 6 • 24 months
|
0.81%
1/123 • Number of events 2 • 24 months
|
2.7%
3/112 • Number of events 4 • 24 months
|
|
Infections and infestations
Infection, access circuit, stent graft
|
0.00%
0/122 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
2.7%
3/112 • Number of events 3 • 24 months
|
|
Infections and infestations
Infection, localized
|
3.3%
4/122 • Number of events 4 • 24 months
|
4.1%
5/123 • Number of events 7 • 24 months
|
7.1%
8/112 • Number of events 10 • 24 months
|
|
Vascular disorders
Ischemia, limb, (non-cardiac)
|
0.00%
0/122 • 24 months
|
1.6%
2/123 • Number of events 2 • 24 months
|
0.00%
0/112 • 24 months
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
2/122 • Number of events 3 • 24 months
|
5.7%
7/123 • Number of events 7 • 24 months
|
1.8%
2/112 • Number of events 3 • 24 months
|
|
Cardiac disorders
Myocardial ischemia
|
0.82%
1/122 • Number of events 1 • 24 months
|
0.00%
0/123 • 24 months
|
0.00%
0/112 • 24 months
|
|
General disorders
Necrosis
|
0.00%
0/122 • 24 months
|
0.00%
0/123 • 24 months
|
1.8%
2/112 • Number of events 2 • 24 months
|
|
Vascular disorders
Peripheral ischemia
|
0.00%
0/122 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
1.8%
2/112 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.9%
6/122 • Number of events 6 • 24 months
|
6.5%
8/123 • Number of events 9 • 24 months
|
5.4%
6/112 • Number of events 6 • 24 months
|
|
Vascular disorders
Pseudoaneurysm
|
0.00%
0/122 • 24 months
|
0.00%
0/123 • 24 months
|
0.89%
1/112 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.6%
2/122 • Number of events 2 • 24 months
|
2.4%
3/123 • Number of events 3 • 24 months
|
4.5%
5/112 • Number of events 7 • 24 months
|
|
Renal and urinary disorders
Renal failure/renal insufficiency
|
3.3%
4/122 • Number of events 4 • 24 months
|
2.4%
3/123 • Number of events 3 • 24 months
|
1.8%
2/112 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.82%
1/122 • Number of events 1 • 24 months
|
0.00%
0/123 • 24 months
|
1.8%
2/112 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
4.1%
5/122 • Number of events 5 • 24 months
|
0.00%
0/123 • 24 months
|
1.8%
2/112 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.1%
5/122 • Number of events 5 • 24 months
|
2.4%
3/123 • Number of events 3 • 24 months
|
3.6%
4/112 • Number of events 5 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection, other
|
1.6%
2/122 • Number of events 2 • 24 months
|
0.00%
0/123 • 24 months
|
1.8%
2/112 • Number of events 2 • 24 months
|
|
Vascular disorders
Restenosis (non-target lesion)
|
4.9%
6/122 • Number of events 13 • 24 months
|
4.9%
6/123 • Number of events 15 • 24 months
|
6.2%
7/112 • Number of events 11 • 24 months
|
|
Vascular disorders
Restenosis of treated segment (target lesion)
|
9.8%
12/122 • Number of events 15 • 24 months
|
17.9%
22/123 • Number of events 35 • 24 months
|
6.2%
7/112 • Number of events 12 • 24 months
|
|
Infections and infestations
SARS, COVID-19
|
2.5%
3/122 • Number of events 3 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
2.7%
3/112 • Number of events 3 • 24 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/122 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
0.89%
1/112 • Number of events 1 • 24 months
|
|
Infections and infestations
Sepsis or systemic infection
|
6.6%
8/122 • Number of events 9 • 24 months
|
5.7%
7/123 • Number of events 9 • 24 months
|
5.4%
6/112 • Number of events 7 • 24 months
|
|
Vascular disorders
Steal syndrome
|
0.82%
1/122 • Number of events 1 • 24 months
|
1.6%
2/123 • Number of events 2 • 24 months
|
0.00%
0/112 • 24 months
|
|
Vascular disorders
Stenosis (non-target)
|
7.4%
9/122 • Number of events 11 • 24 months
|
4.9%
6/123 • Number of events 6 • 24 months
|
6.2%
7/112 • Number of events 8 • 24 months
|
|
Nervous system disorders
Stroke or other neurological complications
|
4.1%
5/122 • Number of events 5 • 24 months
|
3.3%
4/123 • Number of events 6 • 24 months
|
3.6%
4/112 • Number of events 4 • 24 months
|
|
Vascular disorders
Symptomatic distal emboli, non-angiographic
|
0.82%
1/122 • Number of events 1 • 24 months
|
0.00%
0/123 • 24 months
|
0.00%
0/112 • 24 months
|
|
Vascular disorders
Thrombosis
|
5.7%
7/122 • Number of events 8 • 24 months
|
2.4%
3/123 • Number of events 5 • 24 months
|
17.9%
20/112 • Number of events 33 • 24 months
|
|
Vascular disorders
Total occlusion of the vascular access circuit
|
0.82%
1/122 • Number of events 1 • 24 months
|
0.00%
0/123 • 24 months
|
3.6%
4/112 • Number of events 4 • 24 months
|
|
Nervous system disorders
Transient ischemic attack (TIA)
|
0.82%
1/122 • Number of events 1 • 24 months
|
0.00%
0/123 • 24 months
|
0.00%
0/112 • 24 months
|
|
Renal and urinary disorders
Urinary tract infection (UTI)
|
0.00%
0/122 • 24 months
|
1.6%
2/123 • Number of events 2 • 24 months
|
0.00%
0/112 • 24 months
|
|
Vascular disorders
Vascular access complications
|
0.82%
1/122 • Number of events 1 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
0.00%
0/112 • 24 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/122 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
0.89%
1/112 • Number of events 1 • 24 months
|
|
Vascular disorders
Vessel rupture
|
0.82%
1/122 • Number of events 1 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
0.89%
1/112 • Number of events 1 • 24 months
|
|
Vascular disorders
Vessel spasm or recoil
|
0.00%
0/122 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
0.00%
0/112 • 24 months
|
|
General disorders
Pain
|
3.3%
4/122 • Number of events 5 • 24 months
|
3.3%
4/123 • Number of events 4 • 24 months
|
7.1%
8/112 • Number of events 9 • 24 months
|
|
Injury, poisoning and procedural complications
Dialysis Access Complications
|
3.3%
4/122 • Number of events 4 • 24 months
|
1.6%
2/123 • Number of events 4 • 24 months
|
5.4%
6/112 • Number of events 8 • 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.82%
1/122 • Number of events 2 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
2.7%
3/112 • Number of events 4 • 24 months
|
|
Vascular disorders
Aneurysm
|
2.5%
3/122 • Number of events 3 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
0.89%
1/112 • Number of events 1 • 24 months
|
|
Cardiac disorders
Angina
|
0.00%
0/122 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
2.7%
3/112 • Number of events 3 • 24 months
|
|
Cardiac disorders
Arterial bypass surgery
|
0.82%
1/122 • Number of events 1 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
0.89%
1/112 • Number of events 1 • 24 months
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
4/122 • Number of events 4 • 24 months
|
0.81%
1/123 • Number of events 2 • 24 months
|
2.7%
3/112 • Number of events 3 • 24 months
|
|
Vascular disorders
Abrupt vessel closure of treated segment (abrupt occlusion)
|
0.82%
1/122 • Number of events 1 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
0.00%
0/112 • 24 months
|
|
Injury, poisoning and procedural complications
Access (puncture) site complication requiring surgery or transfusion
|
0.00%
0/122 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
0.00%
0/112 • 24 months
|
|
Injury, poisoning and procedural complications
Allergic reaction (medication, contrast media, device, etc.)
|
0.00%
0/122 • 24 months
|
0.00%
0/123 • 24 months
|
0.89%
1/112 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Amputation
|
2.5%
3/122 • Number of events 3 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
4.5%
5/112 • Number of events 7 • 24 months
|
Other adverse events
| Measure |
AVF Peripheral Study Treatment Group
n=122 participants at risk
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
AVF Peripheral Control Group
n=123 participants at risk
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA: Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
|
AVG Anastomosis
n=112 participants at risk
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft: Target lesion treated with stent graft placement
|
|---|---|---|---|
|
Vascular disorders
Stenosis (non-target)
|
32.8%
40/122 • Number of events 62 • 24 months
|
26.0%
32/123 • Number of events 46 • 24 months
|
34.8%
39/112 • Number of events 84 • 24 months
|
|
Vascular disorders
Thrombosis
|
8.2%
10/122 • Number of events 11 • 24 months
|
5.7%
7/123 • Number of events 11 • 24 months
|
25.9%
29/112 • Number of events 58 • 24 months
|
|
General disorders
Pain
|
9.8%
12/122 • Number of events 14 • 24 months
|
7.3%
9/123 • Number of events 12 • 24 months
|
12.5%
14/112 • Number of events 30 • 24 months
|
|
Injury, poisoning and procedural complications
Dialysis Access Complications
|
8.2%
10/122 • Number of events 10 • 24 months
|
2.4%
3/123 • Number of events 5 • 24 months
|
8.0%
9/112 • Number of events 11 • 24 months
|
|
Infections and infestations
Infection, localized
|
4.1%
5/122 • Number of events 6 • 24 months
|
5.7%
7/123 • Number of events 9 • 24 months
|
7.1%
8/112 • Number of events 11 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.9%
6/122 • Number of events 6 • 24 months
|
7.3%
9/123 • Number of events 11 • 24 months
|
6.2%
7/112 • Number of events 7 • 24 months
|
|
Vascular disorders
Pseudoaneurysm
|
0.82%
1/122 • Number of events 1 • 24 months
|
1.6%
2/123 • Number of events 2 • 24 months
|
5.4%
6/112 • Number of events 7 • 24 months
|
|
Vascular disorders
Restenosis (non-target lesion)
|
26.2%
32/122 • Number of events 84 • 24 months
|
25.2%
31/123 • Number of events 70 • 24 months
|
29.5%
33/112 • Number of events 84 • 24 months
|
|
Vascular disorders
Restenosis of treated segment (target lesion)
|
32.0%
39/122 • Number of events 83 • 24 months
|
58.5%
72/123 • Number of events 154 • 24 months
|
19.6%
22/112 • Number of events 39 • 24 months
|
|
Infections and infestations
SARS, COVID-19
|
4.1%
5/122 • Number of events 5 • 24 months
|
3.3%
4/123 • Number of events 4 • 24 months
|
7.1%
8/112 • Number of events 8 • 24 months
|
|
Infections and infestations
Sepsis or systemic infection
|
7.4%
9/122 • Number of events 10 • 24 months
|
5.7%
7/123 • Number of events 9 • 24 months
|
6.2%
7/112 • Number of events 8 • 24 months
|
|
Vascular disorders
Steal syndrome
|
4.1%
5/122 • Number of events 5 • 24 months
|
5.7%
7/123 • Number of events 8 • 24 months
|
6.2%
7/112 • Number of events 7 • 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
1.6%
2/122 • Number of events 4 • 24 months
|
1.6%
2/123 • Number of events 2 • 24 months
|
5.4%
6/112 • Number of events 9 • 24 months
|
|
Infections and infestations
Bacteremia or septicemia
|
4.1%
5/122 • Number of events 5 • 24 months
|
1.6%
2/123 • Number of events 2 • 24 months
|
7.1%
8/112 • Number of events 9 • 24 months
|
|
Vascular disorders
Bleeding complication
|
2.5%
3/122 • Number of events 3 • 24 months
|
4.9%
6/123 • Number of events 6 • 24 months
|
5.4%
6/112 • Number of events 6 • 24 months
|
|
Gastrointestinal disorders
Gastro-intestinal bleeding
|
2.5%
3/122 • Number of events 4 • 24 months
|
1.6%
2/123 • Number of events 3 • 24 months
|
6.2%
7/112 • Number of events 11 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60