Trial Outcomes & Findings for Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft (NCT NCT02649946)
NCT ID: NCT02649946
Last Updated: 2021-12-21
Results Overview
TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at, or adjacent to,the original treatment site or until the extremity is abandoned for permanent access. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV fistula due to inability to treat the original treatment area. COVERA Vascular Covered Stent (following PTA) is evaluated against subjects treated PTA alone.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
280 participants
Primary outcome timeframe
6 months post index procedure
Results posted on
2021-12-21
Participant Flow
Between June 9, 2016, and July 20, 2017, Investigators randomized 280 subjects into the study at 24 sites in the US, Europe, and Australia/New Zealand (50-75% of subjects treated in the US). The final subject completed 6 month follow-up on January 30, 2018. Anticipated data of study completion (last subject, last visit) is Q3, 2019.
Participant milestones
| Measure |
Covera Vascular Covered Stent Following PTA
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Overall Study
STARTED
|
142
|
138
|
|
Overall Study
COMPLETED
|
130
|
123
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
Reasons for withdrawal
| Measure |
Covera Vascular Covered Stent Following PTA
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Death
|
7
|
9
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Erroneously enrolled
|
1
|
0
|
|
Overall Study
Missed 6-month follow-up visit
|
0
|
4
|
Baseline Characteristics
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
Baseline characteristics by cohort
| Measure |
Covera Vascular Covered Stent Following PTA
n=142 Participants
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
n=138 Participants
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 65 years
|
79 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 and < 75 years
|
36 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Age, Customized
≥ 75 years
|
27 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
48 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Island
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
100 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
131 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Medical History
Diabetes (Type 1 and 2)
|
108 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Medical History
Dyslipidemia
|
95 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Medical History
Hypertension
|
139 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Medical History
Cigarette Smoking (current or former)
|
62 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Medical History
Cardiovascular Disease
|
95 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Medical History
Other Disease
|
129 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
|
AV Access Circuit Description: Target Limb
Left Arm
|
106 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
AV Access Circuit Description: Target Limb
Right Arm
|
36 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
AV Access Circuit Description: Access Position
Forearm
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
AV Access Circuit Description: Access Position
Upper Arm
|
132 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
|
AV Access Circuit Description: Access Position
At Elbow
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
AV Access Circuit Description:Inflow Artery
Axillary
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
AV Access Circuit Description:Inflow Artery
Brachial
|
128 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
|
AV Access Circuit Description:Inflow Artery
Radial
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
AV Access Circuit Description: Outflow Vein
Axillary
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
AV Access Circuit Description: Outflow Vein
Basilic
|
35 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
AV Access Circuit Description: Outflow Vein
Cephalic
|
105 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
AV Access Circuit Description: Fistula Configuration
Radiocephalic
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
AV Access Circuit Description: Fistula Configuration
Brachiocephalic
|
84 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
AV Access Circuit Description: Fistula Configuration
Transposed Brachiobasilic
|
27 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
AV Access Circuit Description: Fistula Configuration
All Other
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
AV Access Circuit Description: Transposed
Yes
|
36 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
AV Access Circuit Description: Transposed
No
|
106 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post index procedurePopulation: Number of Participants with Target Lesion Primary Patency. Modified Intended to Treat (mITT) population results were analyzed for this effectiveness endpoint. N = number of subjects in mITT population with evaluable data. Excluded subjects that discontinued, expired and or access abandoned prior to day 15.
TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at, or adjacent to,the original treatment site or until the extremity is abandoned for permanent access. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV fistula due to inability to treat the original treatment area. COVERA Vascular Covered Stent (following PTA) is evaluated against subjects treated PTA alone.
Outcome measures
| Measure |
Covera Vascular Covered Stent Following PTA
n=134 Participants
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
n=117 Participants
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency (TLPP)
|
105 Participants
|
55 Participants
|
PRIMARY outcome
Timeframe: 30 days post index procedurePopulation: Number of Participants Free from Primary Safety Events. All Intended to Treat Subjects (ITT) are included in this analysis. Primary safety endpoint evaluated against standard PTA alone.2 subjects excluded from N COVERA due to discontinuation or death prior to day 23 of follow up. One subject excluded from N PTA arm due to death prior to follow up.
Safety is defined as freedom from any adverse event(s) (AEs), localized or systemic, that reasonably suggests the involvement of the AV access circuit (not including stenosis or thrombosis) that require or result in any of the following alone or in combination: additional interventions (including surgery); in-patient hospitalization or prolongation of an existing hospitalization; or death.
Outcome measures
| Measure |
Covera Vascular Covered Stent Following PTA
n=140 Participants
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
n=137 Participants
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events
|
133 Participants
|
132 Participants
|
SECONDARY outcome
Timeframe: 12 months post-index procedurePopulation: Number of Participants with Target Lesion Primary Patency (TLPP). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 12 month follow-up or did not meet endpoint inclusion criteria.
TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV fistula due to inability to treat the original treatment area.
Outcome measures
| Measure |
Covera Vascular Covered Stent Following PTA
n=124 Participants
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
n=114 Participants
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Number of Patients With Target Lesion Primary Patency (TLPP) at 12 Months Post Index Procedure
|
67 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 6 months post index procedurePopulation: Number of Participants with Access Circuit Primary Patency (ACPP). Modified Intended to Treat (mITT) population results were analyzed for this effectiveness endpoint. N = number of subjects in mITT population with evaluable data. Excluded subjects that discontinued, expired and or access abandoned prior to day 15.
ACPP is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. ACPP ends with a reintervention anywhere within the access circuit. Vessel rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis. Testing of this secondary endpoint is performed in a hierarchical fashion. Thus, In order to perform hypothesis test of ACPP at 6-month, TLPP at 12-months must be successful.
Outcome measures
| Measure |
Covera Vascular Covered Stent Following PTA
n=134 Participants
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
n=117 Participants
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Number of Participants With Access Circuit Primary Patency (ACPP).
|
67 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 1, 3, 18 and 24 months post index procedurePopulation: Number of Participants with Target Lesion Primary Patency (TLPP). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days or 90 days follow-up or did not meet endpoint inclusion criteria.
Defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access. mITT subjects results are presented. N= number of subjects in the mITT Population with evaluable data. Evaluation through 1, 3, 18 and 24 months post index procedure.
Outcome measures
| Measure |
Covera Vascular Covered Stent Following PTA
n=140 Participants
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
n=125 Participants
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Number of Participants With Target Lesion Primary Patency (TLPP)
TLPP at 30-day Follow-up
|
136 Participants
|
122 Participants
|
|
Number of Participants With Target Lesion Primary Patency (TLPP)
TLPP at 90-day Follow-up
|
125 Participants
|
98 Participants
|
|
Number of Participants With Target Lesion Primary Patency (TLPP)
TLPP at 18 month Follow-Up
|
44 Participants
|
16 Participants
|
|
Number of Participants With Target Lesion Primary Patency (TLPP)
TLPP at 24 month Follow-Up
|
40 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 1, 3, 12, 18, and 24 months post index procedurePopulation: Number of Participants with ACPP by Follow-up Period (mITT subjects). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days and 90 days follow-up or did not meet endpoint inclusion criteria.
ACPP is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. N = number of subjects in the mITT Population with evaluable data.
Outcome measures
| Measure |
Covera Vascular Covered Stent Following PTA
n=140 Participants
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
n=125 Participants
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Number of Participants With Access Circuit Primary Patency (ACPP)
ACPP at 30-day Follow-up
|
133 Participants
|
120 Participants
|
|
Number of Participants With Access Circuit Primary Patency (ACPP)
ACPP at 90-day Follow-up
|
110 Participants
|
95 Participants
|
|
Number of Participants With Access Circuit Primary Patency (ACPP)
ACPP at 12-month Follow-Up
|
33 Participants
|
19 Participants
|
|
Number of Participants With Access Circuit Primary Patency (ACPP)
ACPP at 18 month Follow-Up
|
17 Participants
|
13 Participants
|
|
Number of Participants With Access Circuit Primary Patency (ACPP)
ACPP at 24 month Follow-Up
|
13 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Evaluation through 1, 3, 6, 12, 18, and 24 months post-index procedurePopulation: Number of Participants Free from Device and Procedure (DP) Related AEs Involving the AV Access Circuit (ITT subjects). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria.
Number of Participants Free from Device and Procedure Related AEs Involving the AV Access Circuit (ITT population). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria. The relationships with device/procedure of the events are based on CEC adjudications.
Outcome measures
| Measure |
Covera Vascular Covered Stent Following PTA
n=140 Participants
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
n=137 Participants
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Number of Participants Free From Device and Procedure Related AEs Involving the AV Access Circuit
DP AEs Free at 30 day Follow-up
|
127 Participants
|
132 Participants
|
|
Number of Participants Free From Device and Procedure Related AEs Involving the AV Access Circuit
DP AEs Free at 90 day Follow-up
|
124 Participants
|
127 Participants
|
|
Number of Participants Free From Device and Procedure Related AEs Involving the AV Access Circuit
DP AEs Free at 6 month Follow-up
|
118 Participants
|
122 Participants
|
|
Number of Participants Free From Device and Procedure Related AEs Involving the AV Access Circuit
DP AEs Free at 12 month Follow-up
|
108 Participants
|
112 Participants
|
|
Number of Participants Free From Device and Procedure Related AEs Involving the AV Access Circuit
DP AEs Free at 18 month Follow-Up
|
99 Participants
|
102 Participants
|
|
Number of Participants Free From Device and Procedure Related AEs Involving the AV Access Circuit
DP AEs Free at 24 month Follow-up
|
91 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: 1, 3, 6, 12, 18 and 24 months post index procedurePopulation: The (n) in each follow-up periods vary from overall enrollment (N) as some subjects discontinued participation before each follow-up or did not meet endpoint inclusion criteria. The total number of Reinterventions by Follow-Up Period was analyzed as opposed to the number of subjects with at least one AV Access Circuit Reintervention -mITT subjects
Defined as the number of reinterventions to the AV access circuit until access abandonment or through study completion. Whereas the outcome measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, the interim report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study. MITT results are presented for this analysis.
Outcome measures
| Measure |
Covera Vascular Covered Stent Following PTA
n=112 Participants
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
n=107 Participants
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Total Number of Arteriovenous (AV) Access Circuit Reinterventions
AV Access Circuit Reinterventions at 18 months
|
310 AV Access Circuit Reinterventions
|
313 AV Access Circuit Reinterventions
|
|
Total Number of Arteriovenous (AV) Access Circuit Reinterventions
AV Access Circuit Reinterventions at 24 months
|
390 AV Access Circuit Reinterventions
|
398 AV Access Circuit Reinterventions
|
|
Total Number of Arteriovenous (AV) Access Circuit Reinterventions
AV Access Circuit Reinterventions at 30 days
|
7 AV Access Circuit Reinterventions
|
6 AV Access Circuit Reinterventions
|
|
Total Number of Arteriovenous (AV) Access Circuit Reinterventions
AV Access Circuit Reinterventions at 90 days
|
35 AV Access Circuit Reinterventions
|
34 AV Access Circuit Reinterventions
|
|
Total Number of Arteriovenous (AV) Access Circuit Reinterventions
AV Access Circuit Reinterventions at 6 months
|
103 AV Access Circuit Reinterventions
|
107 AV Access Circuit Reinterventions
|
|
Total Number of Arteriovenous (AV) Access Circuit Reinterventions
AV Access Circuit Reinterventions at 12 months
|
226 AV Access Circuit Reinterventions
|
241 AV Access Circuit Reinterventions
|
SECONDARY outcome
Timeframe: 1, 3, 6, 12, 18 and 24 months post index procedurePopulation: The (n) in each follow-up periods vary from overall enrollment (N) as some subjects discontinued participation before each follow-up or did not meet endpoint inclusion criteria. The total number of Target Lesion Reinterventions by Follow-Up Period was analyzed as opposed to the number of subjects with at least one AV Target Lesion Reintervention.
Total Number of Target Lesion Reinterventions defined as the number of reinterventions to maintain target lesion patency (mITT subjects). Whereas the outcome measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months.
Outcome measures
| Measure |
Covera Vascular Covered Stent Following PTA
n=76 Participants
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
n=103 Participants
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Total Number of Target Lesion Reinterventions
Target Lesion Reinterventions at 30 day Follow-up
|
5 Target Lesion Reinterventions
|
3 Target Lesion Reinterventions
|
|
Total Number of Target Lesion Reinterventions
Target Lesion Reinterventions at 90 day Follow-up
|
16 Target Lesion Reinterventions
|
24 Target Lesion Reinterventions
|
|
Total Number of Target Lesion Reinterventions
Target Lesion Reinterventions 6 month Follow-up
|
40 Target Lesion Reinterventions
|
92 Target Lesion Reinterventions
|
|
Total Number of Target Lesion Reinterventions
Target Lesion Reinterventions at 12 month Follow-Up
|
95 Target Lesion Reinterventions
|
196 Target Lesion Reinterventions
|
|
Total Number of Target Lesion Reinterventions
Target Lesion Reintervention at 18 month Follow-Up
|
139 Target Lesion Reinterventions
|
248 Target Lesion Reinterventions
|
|
Total Number of Target Lesion Reinterventions
Target Lesion Reintervention at 24 month Follow-Up
|
179 Target Lesion Reinterventions
|
309 Target Lesion Reinterventions
|
SECONDARY outcome
Timeframe: 1, 3, 6, 12, 18 and 24 months post index procedurePopulation: Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria. mITT subjects results are presented.
IPF is defined as the time from the index study procedure to study completion or access abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis. A visit is defined as one (1) procedural event, regardless of the number or type of interventions performed during the visit. The index procedure is counted as the first visit to ensure all subjects have a denominator of at least one. Whereas the measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months. The IPF is representative of the number of days between interventions to maintain access circuit patency. Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions. mITT results are analyzed.
Outcome measures
| Measure |
Covera Vascular Covered Stent Following PTA
n=140 Participants
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
n=125 Participants
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Index of Patency Function (IPF)
Index of Patency at 6 month Follow-up
|
126.06 Days
Standard Deviation 54.449
|
116.11 Days
Standard Deviation 53.175
|
|
Index of Patency Function (IPF)
Index of Patency at 12 month Follow-up
|
172.04 Days
Standard Deviation 108.690
|
146.09 Days
Standard Deviation 89.723
|
|
Index of Patency Function (IPF)
Index of Patency at 18 month Follow-up
|
199.31 Days
Standard Deviation 145.278
|
175.70 Days
Standard Deviation 125.145
|
|
Index of Patency Function (IPF)
Index of Patency at 24 month Follow-up
|
219.45 Days
Standard Deviation 178.916
|
180.59 Days
Standard Deviation 135.216
|
|
Index of Patency Function (IPF)
Index of Patency at 30 days Follow-up
|
29.22 Days
Standard Deviation 3.420
|
29.28 Days
Standard Deviation 3.219
|
|
Index of Patency Function (IPF)
Index of Patency at 90 days Follow-up
|
79.41 Days
Standard Deviation 20.511
|
78.98 Days
Standard Deviation 20.770
|
SECONDARY outcome
Timeframe: 1, 3, 6, 12, 18 and 24 months post index procedurePopulation: Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria. mITT subjects results are presented.
IPF-T (Index of Patency Function - Target Lesion) is defined as the time from the index study procedure to study completion or complete access abandonment divided by the number of visits for a reintervention performed at the target lesion in order to maintain vascular access for hemodialysis. Whereas the measure time frames for the overall study are 1, 3, 6, 12, 18 and 24 months. The IPF for target lesion patency is representative of the approximate (mean) number of days between interventions to maintain target lesion patency. Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions.
Outcome measures
| Measure |
Covera Vascular Covered Stent Following PTA
n=140 Participants
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
n=125 Participants
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Index of Patency Function - Target Lesion (IPF-T)
IPTF-T at 30 days Follow-Up
|
29.44 Days
Standard Deviation 2.958
|
29.64 Days
Standard Deviation 2.305
|
|
Index of Patency Function - Target Lesion (IPF-T)
IPTF-T at 90 days Follow-Up
|
85.15 Days
Standard Deviation 15.349
|
81.35 Days
Standard Deviation 18.243
|
|
Index of Patency Function - Target Lesion (IPF-T)
IPTF-T at 6 month Follow-Up
|
156.32 Days
Standard Deviation 43.724
|
121.75 Days
Standard Deviation 51.940
|
|
Index of Patency Function - Target Lesion (IPF-T)
IPTF-T at 12 month Follow-up
|
256.32 Days
Standard Deviation 115.626
|
160.37 Days
Standard Deviation 87.504
|
|
Index of Patency Function - Target Lesion (IPF-T)
IPTF-T at 18 month Follow-Up
|
318.24 Days
Standard Deviation 179.651
|
200.64 Days
Standard Deviation 130.055
|
|
Index of Patency Function - Target Lesion (IPF-T)
IPTF-T at 24 month Follow-Up
|
380.40 Days
Standard Deviation 249.548
|
217.57 Days
Standard Deviation 158.373
|
SECONDARY outcome
Timeframe: 1, 3, 6, 12, 18 and 24 months post index procedurePopulation: Post-Intervention Secondary Patency by Follow-Up Period (mITT Subjects). (n) varies in relation to the number of failures (access abandonment) recorded at 30 days, 90 days and 6 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.
Secondary Patency is defined as the interval after the index intervention until the access is abandoned. Multiple repetitive treatments can be included in post-intervention secondary patency. Whereas the measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, the interim report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study. mITT subjects results are presented.
Outcome measures
| Measure |
Covera Vascular Covered Stent Following PTA
n=140 Participants
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
n=125 Participants
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Number of Participants With Post-intervention Secondary Patency
Participants with Secondary Patency at 30 days
|
139 Participants
|
125 Participants
|
|
Number of Participants With Post-intervention Secondary Patency
Participants with Secondary Patency at 90 days
|
136 Participants
|
119 Participants
|
|
Number of Participants With Post-intervention Secondary Patency
Participants with Secondary Patency at 6 months
|
131 Participants
|
113 Participants
|
|
Number of Participants With Post-intervention Secondary Patency
Participants with Secondary Patency at 12 months
|
115 Participants
|
102 Participants
|
|
Number of Participants With Post-intervention Secondary Patency
Participants with Secondary Patency at 18 months
|
103 Participants
|
91 Participants
|
|
Number of Participants With Post-intervention Secondary Patency
Participants with Secondary Patency at 24 months
|
95 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: On Day of Index ProcedurePopulation: Number of Participants with Acute Technical Success (mITT Subjects). Please note that "Technical Success is defined as successful deployment, based on the operator's opinion, of the implant to the intended location assessed at the time of the index procedure." Therefore, for this measure, only COVERA data are relevant.
Technical Success is defined as successful deployment, based on the operator's opinion, of the implant to the intended location assessed at the time of the index procedure. Therefore, for this measure, only COVERA data are relevant. mITT results are presented. Number of participants (n) included in this analysis is different from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria. Technical success was assessed on the day the index procedure was performed, which may be a different day for each participant.
Outcome measures
| Measure |
Covera Vascular Covered Stent Following PTA
n=140 Participants
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Number of Participants With Technical Success
|
140 Participants
|
—
|
SECONDARY outcome
Timeframe: On Day of Index ProcedurePopulation: Procedure Success (mITT Subjects). Number of participants (n) included in this analysis is different from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria.
Procedure Success is defined as anatomic success and resolution of the pre-procedural clinical indicator(s) (clinical success) of a hemodynamically significant stenosis. Procedure success was assessed on the day the index procedure was performed, which may be a different day for each participant.
Outcome measures
| Measure |
Covera Vascular Covered Stent Following PTA
n=140 Participants
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
n=126 Participants
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Number of Participants With Procedure Success
|
138 Participants
|
124 Participants
|
Adverse Events
Covera Vascular Covered Stent Following PTA
Serious events: 107 serious events
Other events: 119 other events
Deaths: 27 deaths
PTA Only Using Uncoated PTA Balloon
Serious events: 110 serious events
Other events: 120 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Covera Vascular Covered Stent Following PTA
n=142 participants at risk
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
n=138 participants at risk
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic
|
2.8%
4/142 • Number of events 4 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
2.9%
4/138 • Number of events 4 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Cardiac disorders
Cardiac disorders
|
21.8%
31/142 • Number of events 31 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
29.0%
40/138 • Number of events 40 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Eye disorders
Eye disorders
|
0.70%
1/142 • Number of events 1 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
0.00%
0/138 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Gastrointestinal disorders
Gastrointestinal
|
14.1%
20/142 • Number of events 20 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
9.4%
13/138 • Number of events 13 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
General disorders
General disorders and administration site conditions
|
13.4%
19/142 • Number of events 19 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
4.3%
6/138 • Number of events 6 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Infections and infestations
Infections and Infestations
|
33.1%
47/142 • Number of events 47 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
26.8%
37/138 • Number of events 37 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
26.1%
37/142 • Number of events 37 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
24.6%
34/138 • Number of events 34 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Investigations
Investigations
|
0.70%
1/142 • Number of events 1 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
0.00%
0/138 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition
|
19.0%
27/142 • Number of events 27 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
16.7%
23/138 • Number of events 23 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Musculoskeletal and connective tissue disorders
Muskuloskeletal and connective disorders
|
2.1%
3/142 • Number of events 3 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
0.72%
1/138 • Number of events 1 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
0.70%
1/142 • Number of events 1 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
4.3%
6/138 • Number of events 6 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Nervous system disorders
Nervous system
|
9.9%
14/142 • Number of events 14 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
10.1%
14/138 • Number of events 14 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Psychiatric disorders
Psychiatric
|
0.70%
1/142 • Number of events 1 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
3.6%
5/138 • Number of events 5 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Renal and urinary disorders
Renal and urinary
|
8.5%
12/142 • Number of events 12 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
10.1%
14/138 • Number of events 14 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal
|
13.4%
19/142 • Number of events 19 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
10.9%
15/138 • Number of events 15 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue
|
4.2%
6/142 • Number of events 6 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
2.2%
3/138 • Number of events 3 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Vascular disorders
Vascular
|
17.6%
25/142 • Number of events 25 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
17.4%
24/138 • Number of events 24 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Surgical and medical procedures
Surgical and medical procedures
|
0.70%
1/142 • Number of events 1 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
0.00%
0/138 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
Other adverse events
| Measure |
Covera Vascular Covered Stent Following PTA
n=142 participants at risk
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
|
PTA Only Using Uncoated PTA Balloon
n=138 participants at risk
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic
|
4.2%
6/142 • Number of events 6 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
6.5%
9/138 • Number of events 9 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Cardiac disorders
Cardiac
|
27.5%
39/142 • Number of events 39 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
31.9%
44/138 • Number of events 44 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Ear and labyrinth disorders
Ear and labyrinth
|
1.4%
2/142 • Number of events 2 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
0.72%
1/138 • Number of events 1 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Endocrine disorders
Endocrine
|
0.70%
1/142 • Number of events 1 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
2.2%
3/138 • Number of events 3 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Eye disorders
Eye
|
2.1%
3/142 • Number of events 3 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
0.72%
1/138 • Number of events 1 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Gastrointestinal disorders
Gastrointestinal
|
20.4%
29/142 • Number of events 29 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
17.4%
24/138 • Number of events 24 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
General disorders
General disorders
|
17.6%
25/142 • Number of events 25 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
10.9%
15/138 • Number of events 15 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Hepatobiliary disorders
Hepatobiliary
|
2.1%
3/142 • Number of events 3 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
5.8%
8/138 • Number of events 8 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Immune system disorders
Immune system
|
0.00%
0/142 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
1.4%
2/138 • Number of events 2 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Infections and infestations
Infections and Infestations
|
42.3%
60/142 • Number of events 60 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
31.2%
43/138 • Number of events 43 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
39.4%
56/142 • Number of events 56 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
32.6%
45/138 • Number of events 45 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Investigations
Investigations
|
2.8%
4/142 • Number of events 4 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
2.9%
4/138 • Number of events 4 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
23.2%
33/142 • Number of events 33 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
23.9%
33/138 • Number of events 33 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Musculoskeletal and connective tissue disorders
Muskuloskeletal and connective tissues
|
14.1%
20/142 • Number of events 20 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
8.7%
12/138 • Number of events 12 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm benign, malignant and unspecified
|
2.1%
3/142 • Number of events 3 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
4.3%
6/138 • Number of events 6 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Nervous system disorders
Nervous system disorders
|
14.8%
21/142 • Number of events 21 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
15.2%
21/138 • Number of events 21 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Psychiatric disorders
Psychiatric
|
1.4%
2/142 • Number of events 2 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
6.5%
9/138 • Number of events 9 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Renal and urinary disorders
Renal and urinary
|
9.2%
13/142 • Number of events 13 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
10.1%
14/138 • Number of events 14 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Reproductive system and breast disorders
Reproductive system and breast
|
0.70%
1/142 • Number of events 1 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
0.00%
0/138 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal
|
17.6%
25/142 • Number of events 25 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
17.4%
24/138 • Number of events 24 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue
|
7.7%
11/142 • Number of events 11 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
5.1%
7/138 • Number of events 7 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
|
Vascular disorders
Vascular
|
26.1%
37/142 • Number of events 37 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
25.4%
35/138 • Number of events 35 • Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
|
Additional Information
Heather Lam, Associate Project Manager, Clinical Affairs
BD/Bard
Phone: (763) 390-8616
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to PI publication of site results, sponsor requires publication of multi-centers results.
- Publication restrictions are in place
Restriction type: OTHER