REVISE: GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
Sponsor
W.L.Gore & Associates (Industry)
Overall Status
Completed
CT.gov ID
NCT00737672
Collaborator
(none)
293
31
2
57
9.5
0.2
Study Details
Study Description
Brief Summary
The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The primary effectiveness hypothesis is to demonstrate that the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface will extend the period of target lesion primary patency as compared to PTA.
The primary safety hypothesis is to demonstrate that the proportion of subjects remaining free from major device, procedure, and treatment site-related adverse events through 30 days post-procedure in the GORE® VIABAHN® Device group is not inferior to that of the PTA group.
Study Design
Study Type:
Interventional
Actual Enrollment
:
293 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients
Study Start Date
:
Sep 1, 2008
Actual Primary Completion Date
:
May 1, 2011
Actual Study Completion Date
:
Jun 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VIABAHN Treatment Group Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm |
Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
Deployment of investigational stent graft at the venous anastomosis
|
| Active Comparator: PTA Treatment Group Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm |
Procedure: Percutaneous Transluminal Angioplasty
Percutaneous Transluminal Angioplasty at the venous anastomosis
|
Outcome Measures
Primary Outcome Measures
- Target Lesion Primary Patency at 6 Months [6 months]
Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve.
- Target Lesion Primary Patency at 12 Months [12 Months]
Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Twelve-month estimate of target lesion primary patency derived from Kaplan-Meier curve.
- Target Lesion Primary Patency at 24 Months [24 Months]
Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. P-Value calculated from 24-month data cohort after study completion.
- Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure [30 days]
The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.
Secondary Outcome Measures
- Assisted Primary Patency at 6 Months [6 months]
Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Six-month estimate of assisted primary patency derived from Kaplan-Meier curve.
- Assisted Primary Patency at 12 Months [12 months]
Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Twelve-month estimate of assisted primary patency derived from Kaplan-Meier curve.
- Assisted Primary Patency at 24 Months [24 months]
Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Twenty-four-month estimate of assisted primary patency derived from Kaplan-Meier curve.
- Access Secondary Patency at 6 Months [6 months]
Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Six-month estimate of secondary access patency derived from Kaplan-Meier curve.
- Access Secondary Patency [12 Months] Units Percentage of Subjects [12 months]
Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.
- Access Secondary Patency [24 Months] Units Percentage of Subjects [24 months]
Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. 24-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.
- Circuit Primary Patency [6 months]
Kaplan-Meier estimate of the time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit. P-Value calculated from 24-month data cohort. Six-month estimate of circuit primary patency derived from Kaplan-Meier curve.
- Circuit Primary Patency [12 Months] Units Percentage of Subjects [12months]
Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.
- Circuit Primary Patency [24 Months] Units Percentage of Subjects [24 months]
Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.
- Clinical Success [Following Index Procedure]
The resumption of normal dialysis for at least one session following study treatment (Index Procedure).
- Anatomic Success [Index Procedure]
Less than 30 percent residual stenosis following study treatment (Index Procedure).
- Procedural Success [Following Index Procedure]
Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Hemodialysis patient with a dysfunctional or thrombosed forearm or upper arm prosthetic vascular access graft.
-
The target lesion starts less than or equal to 30 mm from the venous anastomosis.
-
The target lesion has > 50% stenosis as measured per protocol.
-
The patient has a maximum of one secondary stenosis.
Exclusion Criteria:
-
The age of the hemodialysis access graft is less than or equal to 30 days old from the date of the study procedure.
-
The patient has undergone an intervention (surgical or percutaneous) of the vascular access circuit less than or equal to 30 days from the date of the study procedure.
-
The secondary lesion is an occlusion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | 35249 | |
| 2 | Fresno | California | United States | 93710 | |
| 3 | Inglewood | California | United States | 90301 | |
| 4 | Oceanside | California | United States | 92056 | |
| 5 | Riverside | California | United States | 92501 | |
| 6 | San Diego | California | United States | 92115 | |
| 7 | San Diego | California | United States | 92120 | |
| 8 | San Francisco | California | United States | 94143 | |
| 9 | New Haven | Connecticut | United States | 06520 | |
| 10 | Jacksonville | Florida | United States | 32209 | |
| 11 | Albany | Georgia | United States | 31707-1908 | |
| 12 | Chicago | Illinois | United States | 60612-3833 | |
| 13 | Des Moines | Iowa | United States | 50309 | |
| 14 | Louisville | Kentucky | United States | 40202 | |
| 15 | Baltimore | Maryland | United States | 21239 | |
| 16 | New Brighton | Minnesota | United States | 55112 | |
| 17 | St. Paul | Minnesota | United States | 55101 | |
| 18 | Cincinnati | Ohio | United States | 45212 | |
| 19 | Cincinnati | Ohio | United States | 45267-0585 | |
| 20 | Dayton | Ohio | United States | 45406 | |
| 21 | Portland | Oregon | United States | 97210 | |
| 22 | Philadelphia | Pennsylvania | United States | 19104 | |
| 23 | Charleston | South Carolina | United States | 29421 | |
| 24 | Greenville | South Carolina | United States | 29615 | |
| 25 | Beaumont | Texas | United States | 77701 | |
| 26 | Houston | Texas | United States | 77030 | |
| 27 | Norfolk | Virginia | United States | 23507 | |
| 28 | Winchester | Virginia | United States | 22601 | |
| 29 | Bellevue | Washington | United States | 98004 | |
| 30 | Spokane | Washington | United States | 99204 | |
| 31 | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- W.L.Gore & Associates
Investigators
- Study Director: Tom Vesely, MD, Vascular Access Center; Frontenac, MO
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00737672
Other Study ID Numbers:
- AVR 06-01
- G070069
First Posted:
Aug 19, 2008
Last Update Posted:
Oct 21, 2014
Last Verified:
Oct 1, 2014
Keywords provided by W.L.Gore & Associates
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA)in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Period Title: Overall Study | ||
| STARTED | 145 | 148 |
| Exclusions Due to Protocol Deviations | 14 | 10 |
| Per Protocol Population | 131 | 138 |
| COMPLETED | 65 | 65 |
| NOT COMPLETED | 80 | 83 |
Baseline Characteristics
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group | Total |
|---|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm. GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis. | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm. Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis. | Total of all reporting groups |
| Overall Participants | 145 | 148 | 293 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
62.2
(12.9)
|
61.3
(15.0)
|
61.7
(14.0)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
76
52.4%
|
75
50.7%
|
151
51.5%
|
| Male |
69
47.6%
|
73
49.3%
|
142
48.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
16
11%
|
30
20.3%
|
46
15.7%
|
| Not Hispanic or Latino |
126
86.9%
|
114
77%
|
240
81.9%
|
| Unknown or Not Reported |
3
2.1%
|
4
2.7%
|
7
2.4%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
1
0.7%
|
1
0.3%
|
| Asian |
9
6.2%
|
7
4.7%
|
16
5.5%
|
| Native Hawaiian or Other Pacific Islander |
1
0.7%
|
0
0%
|
1
0.3%
|
| Black or African American |
74
51%
|
80
54.1%
|
154
52.6%
|
| White |
61
42.1%
|
56
37.8%
|
117
39.9%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
4
2.7%
|
4
1.4%
|
| Region of Enrollment (Number) [Number] | |||
| United States |
145
100%
|
148
100%
|
293
100%
|
| Body Mass Index (Kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Kg/m^2] |
29.7
(9.1)
|
29.5
(8.6)
|
29.6
(8.8)
|
| History of Diabetes (Number) [Number] | |||
| History of Diabetes = YES |
94
(64.8)
64.8%
|
98
(66.2)
66.2%
|
192
65.5%
|
| History of Diabetes = NO |
51
35.2%
|
50
33.8%
|
101
34.5%
|
| History of Hypertension (Number) [Number] | |||
| History of Hypertension = YES |
143
98.6%
|
144
97.3%
|
287
98%
|
| History of Hypertension = NO |
2
1.4%
|
4
2.7%
|
6
2%
|
| Age of Vascular Access Graft (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
1.93
(1.92)
|
2.28
(2.64)
|
2.11
(2.31)
|
| Total Number of Prior Interventions at the Target Lesions (Number of Prior Interventions) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Number of Prior Interventions] |
1.85
(2.20)
|
1.81
(2.34)
|
1.83
(2.27)
|
| Total Number of Prior Interventions to the Current Prosthetic Graft or Circuit (Number of Prior Interventions) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Number of Prior Interventions] |
2.28
(2.75)
|
2.26
(2.90)
|
2.27
(2.82)
|
Outcome Measures
| Title | Target Lesion Primary Patency at 6 Months |
|---|---|
| Description | Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population. |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Measure Participants | 131 | 138 |
| Number (95% Confidence Interval) [Percentage of Subjects] |
52.9
|
35.5
|
| Title | Target Lesion Primary Patency at 12 Months |
|---|---|
| Description | Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Twelve-month estimate of target lesion primary patency derived from Kaplan-Meier curve. |
| Time Frame | 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population. |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Measure Participants | 131 | 138 |
| Number (95% Confidence Interval) [Percentage of Subjects] |
30.2
|
18.2
|
| Title | Assisted Primary Patency at 6 Months |
|---|---|
| Description | Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Six-month estimate of assisted primary patency derived from Kaplan-Meier curve. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population. |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Measure Participants | 131 | 138 |
| Number (95% Confidence Interval) [Percentage of Subjects] |
56.2
|
51.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VIABAHN Treatment Group, PTA Treatment Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.530 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Assisted Primary Patency at 12 Months |
|---|---|
| Description | Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Twelve-month estimate of assisted primary patency derived from Kaplan-Meier curve. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population. |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Measure Participants | 131 | 138 |
| Number (95% Confidence Interval) [Percentage of Subjects] |
43.5
|
35.3
|
| Title | Assisted Primary Patency at 24 Months |
|---|---|
| Description | Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Twenty-four-month estimate of assisted primary patency derived from Kaplan-Meier curve. |
| Time Frame | 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population. |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Measure Participants | 131 | 138 |
| Number (95% Confidence Interval) [Percentage of Subjects] |
29.2
|
29.0
|
| Title | Access Secondary Patency at 6 Months |
|---|---|
| Description | Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Six-month estimate of secondary access patency derived from Kaplan-Meier curve. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population. |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Measure Participants | 131 | 138 |
| Number (95% Confidence Interval) [Percentage of Subjects] |
91.2
|
86.5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VIABAHN Treatment Group, PTA Treatment Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.475 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Access Secondary Patency [12 Months] Units Percentage of Subjects |
|---|---|
| Description | Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population. |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Measure Participants | 100 | 104 |
| Number (95% Confidence Interval) [Percentage of Subjects] |
82.7
|
78.6
|
| Title | Access Secondary Patency [24 Months] Units Percentage of Subjects |
|---|---|
| Description | Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. 24-month estimate of secondary access secondary patency derived from Kaplan-Meier curve. |
| Time Frame | 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population. |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Measure Participants | 77 | 72 |
| Number (95% Confidence Interval) [Percentage of Subjects] |
68.9
|
66.6
|
| Title | Target Lesion Primary Patency at 24 Months |
|---|---|
| Description | Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. P-Value calculated from 24-month data cohort after study completion. |
| Time Frame | 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population. |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Measure Participants | 131 | 138 |
| Number (95% Confidence Interval) [Percentage of Subjects] |
15.7
|
9.9
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VIABAHN Treatment Group, PTA Treatment Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | P-value was calculated using Kaplan-Meier methodology with 24-month follow-up data. | |
| Method | Log Rank | |
| Comments | ||
| Title | Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure |
|---|---|
| Description | The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days. |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Measure Participants | 145 | 148 |
| Number [Participants] |
0
0%
|
2
1.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VIABAHN Treatment Group, PTA Treatment Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | One-sided test of non-inferior proportions with delta = 0.15. | |
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Z-test | |
| Comments | One-sided. | |
| Title | Circuit Primary Patency |
|---|---|
| Description | Kaplan-Meier estimate of the time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit. P-Value calculated from 24-month data cohort. Six-month estimate of circuit primary patency derived from Kaplan-Meier curve. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Measure Participants | 145 | 148 |
| Number (95% Confidence Interval) [Percentage of Subjects] |
43.4
|
29.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VIABAHN Treatment Group, PTA Treatment Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.035 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Circuit Primary Patency [12 Months] Units Percentage of Subjects |
|---|---|
| Description | Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve. |
| Time Frame | 12months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population. |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Measure Participants | 48 | 38 |
| Number (95% Confidence Interval) [Percentage of Subjects] |
21.4
|
15.2
|
| Title | Circuit Primary Patency [24 Months] Units Percentage of Subjects |
|---|---|
| Description | Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve. |
| Time Frame | 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population. |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Measure Participants | 12 | 9 |
| Number (95% Confidence Interval) [Percentage of Subjects] |
9.6
|
6.8
|
| Title | Clinical Success |
|---|---|
| Description | The resumption of normal dialysis for at least one session following study treatment (Index Procedure). |
| Time Frame | Following Index Procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Measure Participants | 131 | 138 |
| Clinical Success = YES |
128
88.3%
|
135
91.2%
|
| Clinical Success = NO |
3
2.1%
|
3
2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VIABAHN Treatment Group, PTA Treatment Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.000 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | Two-tailed. | |
| Title | Anatomic Success |
|---|---|
| Description | Less than 30 percent residual stenosis following study treatment (Index Procedure). |
| Time Frame | Index Procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Measure Participants | 131 | 138 |
| Anatomic Success = YES |
131
90.3%
|
116
78.4%
|
| Anatomic Success = NO |
0
0%
|
22
14.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VIABAHN Treatment Group, PTA Treatment Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | Two-tailed. | |
| Title | Procedural Success |
|---|---|
| Description | Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success. |
| Time Frame | Following Index Procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group |
|---|---|---|
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis |
| Measure Participants | 131 | 138 |
| Procedural Success = YES |
128
88.3%
|
113
76.4%
|
| Procedural Success = NO |
3
2.1%
|
25
16.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VIABAHN Treatment Group, PTA Treatment Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | Two-tailed. | |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | VIABAHN Treatment Group | PTA Treatment Group | ||
| Arm/Group Description | Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm | Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm | ||
All Cause Mortality |
||||
| VIABAHN Treatment Group | PTA Treatment Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| VIABAHN Treatment Group | PTA Treatment Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 78/145 (53.8%) | 77/148 (52%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 1/145 (0.7%) | 1/148 (0.7%) | ||
| Anemia of chronic disease | 1/145 (0.7%) | 0/148 (0%) | ||
| Hypercoagulation | 0/145 (0%) | 1/148 (0.7%) | ||
| Leukopenia | 0/145 (0%) | 1/148 (0.7%) | ||
| Thrombocytopenia | 1/145 (0.7%) | 0/148 (0%) | ||
| Cardiac disorders | ||||
| Acute coronary syndrome | 1/145 (0.7%) | 0/148 (0%) | ||
| Anginal pain | 3/145 (2.1%) | 1/148 (0.7%) | ||
| Atrial fibrillation | 2/145 (1.4%) | 2/148 (1.4%) | ||
| Atrial fibrillation with rapid ventricular response | 0/145 (0%) | 1/148 (0.7%) | ||
| Atrial flutter | 0/145 (0%) | 1/148 (0.7%) | ||
| Bradycardia | 4/145 (2.8%) | 2/148 (1.4%) | ||
| Cardiac arrest | 6/145 (4.1%) | 8/148 (5.4%) | ||
| Cardiopulmonary arrest | 3/145 (2.1%) | 2/148 (1.4%) | ||
| Chest pain | 1/145 (0.7%) | 0/148 (0%) | ||
| Congestive heart failure | 3/145 (2.1%) | 1/148 (0.7%) | ||
| Coronary artery disease | 2/145 (1.4%) | 0/148 (0%) | ||
| Diastolic dysfunction | 0/145 (0%) | 1/148 (0.7%) | ||
| Hypertensive heart disease | 1/145 (0.7%) | 0/148 (0%) | ||
| Junctional bradycardia | 1/145 (0.7%) | 0/148 (0%) | ||
| Myocardial Infarction | 2/145 (1.4%) | 0/148 (0%) | ||
| Myocardial infarction | 4/145 (2.8%) | 0/148 (0%) | ||
| Non STEMI | 3/145 (2.1%) | 1/148 (0.7%) | ||
| Tachycardia NOS | 1/145 (0.7%) | 0/148 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Polycystic hepatorenal disease | 1/145 (0.7%) | 0/148 (0%) | ||
| Endocrine disorders | ||||
| Addison's disease | 0/145 (0%) | 1/148 (0.7%) | ||
| Eye disorders | ||||
| Blurry vision | 1/145 (0.7%) | 0/148 (0%) | ||
| Cataract | 1/145 (0.7%) | 0/148 (0%) | ||
| Retinal detachment | 1/145 (0.7%) | 0/148 (0%) | ||
| Retinal vascular occlusion | 1/145 (0.7%) | 0/148 (0%) | ||
| Gastrointestinal disorders | ||||
| Pancreatitis | 0/145 (0%) | 1/148 (0.7%) | ||
| Abdominal pain | 2/145 (1.4%) | 0/148 (0%) | ||
| Abdominal pain aggravated | 1/145 (0.7%) | 0/148 (0%) | ||
| Abdominal strangulated hernia | 1/145 (0.7%) | 0/148 (0%) | ||
| Acute duodenal ulcer with hemorrhage | 0/145 (0%) | 1/148 (0.7%) | ||
| Acute pancreatitis | 0/145 (0%) | 1/148 (0.7%) | ||
| Bleeding gastric ulcer | 0/145 (0%) | 1/148 (0.7%) | ||
| Blood in stool | 2/145 (1.4%) | 1/148 (0.7%) | ||
| Colitis | 1/145 (0.7%) | 0/148 (0%) | ||
| Diabetic gastroparesis | 1/145 (0.7%) | 1/148 (0.7%) | ||
| Diarrhea | 0/145 (0%) | 1/148 (0.7%) | ||
| Dieulafoy's vascular malformation | 1/145 (0.7%) | 0/148 (0%) | ||
| Diverticulum intestinal hemorrhagic | 0/145 (0%) | 1/148 (0.7%) | ||
| GI bleed | 3/145 (2.1%) | 2/148 (1.4%) | ||
| Gastritis | 1/145 (0.7%) | 0/148 (0%) | ||
| Gastroparesis | 1/145 (0.7%) | 0/148 (0%) | ||
| Hematochezia | 1/145 (0.7%) | 0/148 (0%) | ||
| Incarcerated inguinal hernia | 1/145 (0.7%) | 0/148 (0%) | ||
| Internal hemorrhoids | 1/145 (0.7%) | 0/148 (0%) | ||
| Lower gastrointestinal bleeding | 1/145 (0.7%) | 0/148 (0%) | ||
| Melena | 0/145 (0%) | 1/148 (0.7%) | ||
| Mesenteric ischemia | 1/145 (0.7%) | 0/148 (0%) | ||
| Pancreatitis acute on chronic | 1/145 (0.7%) | 0/148 (0%) | ||
| Pancreatitis due to gallstones | 0/145 (0%) | 1/148 (0.7%) | ||
| Peptic ulcer disease | 1/145 (0.7%) | 0/148 (0%) | ||
| Rectal bleeding | 1/145 (0.7%) | 0/148 (0%) | ||
| Right-sided colitis | 1/145 (0.7%) | 0/148 (0%) | ||
| Small bowel obstruction | 2/145 (1.4%) | 1/148 (0.7%) | ||
| Upper gastrointestinal bleeding | 2/145 (1.4%) | 2/148 (1.4%) | ||
| Upper gastrointestinal symptoms | 2/145 (1.4%) | 0/148 (0%) | ||
| General disorders | ||||
| Adverse drug reaction | 0/145 (0%) | 1/148 (0.7%) | ||
| Catheter site bleeding | 1/145 (0.7%) | 0/148 (0%) | ||
| Chest pain | 8/145 (5.5%) | 6/148 (4.1%) | ||
| Debility marked | 0/145 (0%) | 1/148 (0.7%) | ||
| Ill-defined disorder | 0/145 (0%) | 1/148 (0.7%) | ||
| Incarcerated hernia | 0/145 (0%) | 1/148 (0.7%) | ||
| Intraocular lens dislocation | 0/145 (0%) | 1/148 (0.7%) | ||
| Pain at rest | 0/145 (0%) | 1/148 (0.7%) | ||
| Peritoneal catheter dysfunction | 0/145 (0%) | 1/148 (0.7%) | ||
| Sudden cardiac death | 1/145 (0.7%) | 0/148 (0%) | ||
| Hepatobiliary disorders | ||||
| Acute cholecystitis | 1/145 (0.7%) | 0/148 (0%) | ||
| Biliary stasis | 1/145 (0.7%) | 0/148 (0%) | ||
| Cholelithiasis | 2/145 (1.4%) | 1/148 (0.7%) | ||
| Immune system disorders | ||||
| Allergic reaction to antibiotics | 1/145 (0.7%) | 2/148 (1.4%) | ||
| Infections and infestations | ||||
| Abscess dental | 0/145 (0%) | 1/148 (0.7%) | ||
| Abscess leg | 1/145 (0.7%) | 0/148 (0%) | ||
| Abscess of finger | 1/145 (0.7%) | 0/148 (0%) | ||
| Acute tracheobronchitis | 1/145 (0.7%) | 0/148 (0%) | ||
| Arteriovenous graft site infection | 5/145 (3.4%) | 9/148 (6.1%) | ||
| Bacteremia | 5/145 (3.4%) | 0/148 (0%) | ||
| Bacterial endocarditis | 1/145 (0.7%) | 0/148 (0%) | ||
| Biliary sepsis | 1/145 (0.7%) | 0/148 (0%) | ||
| Bronchitis | 3/145 (2.1%) | 0/148 (0%) | ||
| C.difficile colitis | 2/145 (1.4%) | 0/148 (0%) | ||
| Candida sepsis | 0/145 (0%) | 1/148 (0.7%) | ||
| Cellulitis | 2/145 (1.4%) | 0/148 (0%) | ||
| Cellulitis of arm | 0/145 (0%) | 1/148 (0.7%) | ||
| Cellulitis of foot | 1/145 (0.7%) | 0/148 (0%) | ||
| Cellulitis of leg | 2/145 (1.4%) | 0/148 (0%) | ||
| Cellulitis of legs | 0/145 (0%) | 1/148 (0.7%) | ||
| Community acquired pneumonia | 2/145 (1.4%) | 1/148 (0.7%) | ||
| Diabetic foot infection | 0/145 (0%) | 1/148 (0.7%) | ||
| Diverticulitis | 1/145 (0.7%) | 0/148 (0%) | ||
| Foot infection | 2/145 (1.4%) | 0/148 (0%) | ||
| Gangrene | 5/145 (3.4%) | 5/148 (3.4%) | ||
| Hospital acquired infection | 1/145 (0.7%) | 0/148 (0%) | ||
| Infection of amputation stump | 1/145 (0.7%) | 0/148 (0%) | ||
| Leg infection | 1/145 (0.7%) | 1/148 (0.7%) | ||
| Osteomyelitis | 3/145 (2.1%) | 1/148 (0.7%) | ||
| Pneumonia | 2/145 (1.4%) | 8/148 (5.4%) | ||
| Pneumonia aspergillus | 0/145 (0%) | 1/148 (0.7%) | ||
| Recurrent urinary tract infection | 1/145 (0.7%) | 0/148 (0%) | ||
| Sepsis | 5/145 (3.4%) | 5/148 (3.4%) | ||
| Sepsis MRSA | 1/145 (0.7%) | 2/148 (1.4%) | ||
| Septic shock | 3/145 (2.1%) | 0/148 (0%) | ||
| Shingles | 0/145 (0%) | 1/148 (0.7%) | ||
| Staphylococcal bacteremia | 2/145 (1.4%) | 1/148 (0.7%) | ||
| Staphylococcal sepsis | 0/145 (0%) | 2/148 (1.4%) | ||
| Streptococcal cellulitis | 1/145 (0.7%) | 0/148 (0%) | ||
| Urinary tract infection | 2/145 (1.4%) | 4/148 (2.7%) | ||
| Urosepsis | 1/145 (0.7%) | 0/148 (0%) | ||
| Viral syndrome | 0/145 (0%) | 1/148 (0.7%) | ||
| Injury, poisoning and procedural complications | ||||
| Acute subdural hematoma | 1/145 (0.7%) | 0/148 (0%) | ||
| Arteriovenous fistula thrombosis | 1/145 (0.7%) | 1/148 (0.7%) | ||
| Arteriovenous graft aneurysm | 1/145 (0.7%) | 1/148 (0.7%) | ||
| Arteriovenous graft site bleeding | 4/145 (2.8%) | 3/148 (2%) | ||
| Arteriovenous graft site hematoma | 0/145 (0%) | 2/148 (1.4%) | ||
| Arteriovenous graft site hemorrhage | 1/145 (0.7%) | 0/148 (0%) | ||
| Bleeding postoperative | 1/145 (0.7%) | 0/148 (0%) | ||
| Cervical vertebral fracture C2 | 1/145 (0.7%) | 1/148 (0.7%) | ||
| Fall | 1/145 (0.7%) | 0/148 (0%) | ||
| Fat embolism | 0/145 (0%) | 1/148 (0.7%) | ||
| Femur fracture | 1/145 (0.7%) | 0/148 (0%) | ||
| Fracture of upper end or unspecified part of tibia and fibula, closed | 1/145 (0.7%) | 0/148 (0%) | ||
| Hemodialysis-induced symptom | 0/145 (0%) | 1/148 (0.7%) | ||
| Hip fracture | 1/145 (0.7%) | 1/148 (0.7%) | ||
| Hypotension during dialysis | 0/145 (0%) | 2/148 (1.4%) | ||
| Lower limb wound | 1/145 (0.7%) | 0/148 (0%) | ||
| Pelvic fracture | 0/145 (0%) | 2/148 (1.4%) | ||
| Postoperative bleeding | 0/145 (0%) | 1/148 (0.7%) | ||
| Postoperative thoracic procedure complication | 0/145 (0%) | 1/148 (0.7%) | ||
| Pubic rami fracture | 1/145 (0.7%) | 0/148 (0%) | ||
| Investigations | ||||
| Electrocardiogram abnormal non-specific | 1/145 (0.7%) | 0/148 (0%) | ||
| Troponin increased | 1/145 (0.7%) | 0/148 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Diabetes mellitus poor control | 1/145 (0.7%) | 0/148 (0%) | ||
| Diabetic ketoacidosis | 5/145 (3.4%) | 2/148 (1.4%) | ||
| Hyperglycemia | 2/145 (1.4%) | 0/148 (0%) | ||
| Hyperkalemia | 6/145 (4.1%) | 7/148 (4.7%) | ||
| Hypocalcemia | 1/145 (0.7%) | 1/148 (0.7%) | ||
| Hypoglycemia | 0/145 (0%) | 3/148 (2%) | ||
| Hypokalemia | 1/145 (0.7%) | 1/148 (0.7%) | ||
| Volume overload | 11/145 (7.6%) | 5/148 (3.4%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Avascular necrosis femoral head | 1/145 (0.7%) | 0/148 (0%) | ||
| Hand pain | 0/145 (0%) | 1/148 (0.7%) | ||
| Jaw pain | 1/145 (0.7%) | 0/148 (0%) | ||
| Leg pain | 1/145 (0.7%) | 0/148 (0%) | ||
| Osteoarthritis aggravated | 1/145 (0.7%) | 0/148 (0%) | ||
| Osteoarthritis of cervical spine | 0/145 (0%) | 1/148 (0.7%) | ||
| Pain in arm | 1/145 (0.7%) | 0/148 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Brain cancer metastatic | 1/145 (0.7%) | 0/148 (0%) | ||
| Cholangiocarcinoma | 1/145 (0.7%) | 0/148 (0%) | ||
| Hepatic adenocarcinoma | 0/145 (0%) | 1/148 (0.7%) | ||
| Metastatic renal cell carcinoma | 0/145 (0%) | 1/148 (0.7%) | ||
| Non-small cell lung cancer | 0/145 (0%) | 1/148 (0.7%) | ||
| Renal cell carcinoma | 0/145 (0%) | 1/148 (0.7%) | ||
| Nervous system disorders | ||||
| Cerebrovascular accident | 2/145 (1.4%) | 4/148 (2.7%) | ||
| Dizziness | 1/145 (0.7%) | 0/148 (0%) | ||
| Encephalopathy acute | 0/145 (0%) | 2/148 (1.4%) | ||
| Slurred speech | 1/145 (0.7%) | 0/148 (0%) | ||
| Stroke | 1/145 (0.7%) | 0/148 (0%) | ||
| Syncope | 2/145 (1.4%) | 1/148 (0.7%) | ||
| Tonic-clonic seizures | 0/145 (0%) | 1/148 (0.7%) | ||
| Toxic encephalopathy | 0/145 (0%) | 1/148 (0.7%) | ||
| Transient ischemic attack | 2/145 (1.4%) | 1/148 (0.7%) | ||
| Tremor | 0/145 (0%) | 1/148 (0.7%) | ||
| Psychiatric disorders | ||||
| Mental status changes | 3/145 (2.1%) | 2/148 (1.4%) | ||
| Renal and urinary disorders | ||||
| End stage renal disease (ESRD) | 2/145 (1.4%) | 4/148 (2.7%) | ||
| Hematuria | 0/145 (0%) | 1/148 (0.7%) | ||
| Kidney failure | 1/145 (0.7%) | 0/148 (0%) | ||
| Renal mass | 0/145 (0%) | 2/148 (1.4%) | ||
| Uremia | 0/145 (0%) | 2/148 (1.4%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute on chronic respiratory failure | 1/145 (0.7%) | 0/148 (0%) | ||
| Aspiration pneumonia | 1/145 (0.7%) | 0/148 (0%) | ||
| Asthma | 1/145 (0.7%) | 0/148 (0%) | ||
| Chronic obstructive pulmonary disease | 1/145 (0.7%) | 1/148 (0.7%) | ||
| Flash pulmonary edema | 0/145 (0%) | 1/148 (0.7%) | ||
| Hemoptysis | 0/145 (0%) | 1/148 (0.7%) | ||
| Lung nodule | 0/145 (0%) | 1/148 (0.7%) | ||
| Non-cardiogenic pulmonary edema | 0/145 (0%) | 1/148 (0.7%) | ||
| Orthopnea | 0/145 (0%) | 1/148 (0.7%) | ||
| Pleural effusion | 1/145 (0.7%) | 2/148 (1.4%) | ||
| Pulmonary congestion | 0/145 (0%) | 1/148 (0.7%) | ||
| Pulmonary edema | 0/145 (0%) | 1/148 (0.7%) | ||
| Pulmonary embolism | 0/145 (0%) | 1/148 (0.7%) | ||
| Pulmonary infiltration | 1/145 (0.7%) | 0/148 (0%) | ||
| Respiratory distress | 0/145 (0%) | 1/148 (0.7%) | ||
| Respiratory failure | 2/145 (1.4%) | 0/148 (0%) | ||
| Shortness of breath | 1/145 (0.7%) | 1/148 (0.7%) | ||
| Vocal cord dysfunction | 1/145 (0.7%) | 0/148 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Decubitus ulcer | 0/145 (0%) | 1/148 (0.7%) | ||
| Facial swelling | 1/145 (0.7%) | 0/148 (0%) | ||
| Foot ulcer | 0/145 (0%) | 1/148 (0.7%) | ||
| Heel ulcer | 1/145 (0.7%) | 0/148 (0%) | ||
| Leg ulcer | 1/145 (0.7%) | 0/148 (0%) | ||
| Venous stasis ulcer | 0/145 (0%) | 1/148 (0.7%) | ||
| Surgical and medical procedures | ||||
| Anticoagulant therapy | 1/145 (0.7%) | 0/148 (0%) | ||
| Blood pressure management | 1/145 (0.7%) | 0/148 (0%) | ||
| Kidney transplant | 1/145 (0.7%) | 0/148 (0%) | ||
| Toe amputation | 0/145 (0%) | 1/148 (0.7%) | ||
| Vascular disorders | ||||
| Accelerated Hypertension | 1/145 (0.7%) | 0/148 (0%) | ||
| Arterial embolism NOS | 0/145 (0%) | 1/148 (0.7%) | ||
| Atherosclerosis of arteries of the extremities | 1/145 (0.7%) | 0/148 (0%) | ||
| Critical limb ischemia | 1/145 (0.7%) | 0/148 (0%) | ||
| Deep venous thrombosis arm | 0/145 (0%) | 1/148 (0.7%) | ||
| Hypertension | 1/145 (0.7%) | 1/148 (0.7%) | ||
| Hypertensive emergency | 0/145 (0%) | 1/148 (0.7%) | ||
| Hypertensive urgency | 1/145 (0.7%) | 2/148 (1.4%) | ||
| Malignant hypertension | 1/145 (0.7%) | 1/148 (0.7%) | ||
| Peripheral arterial disease | 1/145 (0.7%) | 2/148 (1.4%) | ||
| Peripheral ischemia | 0/145 (0%) | 2/148 (1.4%) | ||
| Uncontrolled hypertension | 1/145 (0.7%) | 0/148 (0%) | ||
| Venous (peripheral) insufficiency, unspecified | 1/145 (0.7%) | 0/148 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| VIABAHN Treatment Group | PTA Treatment Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/145 (2.8%) | 8/148 (5.4%) | ||
| General disorders | ||||
| Chest pain | 4/145 (2.8%) | 8/148 (5.4%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Clinical Project Manager |
|---|---|
| Organization | W.L. Gore and Associates, Inc. |
| Phone | 928-864-3771 |
| cavery@wlgore.com |
Responsible Party:
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00737672
Other Study ID Numbers:
- AVR 06-01
- G070069
First Posted:
Aug 19, 2008
Last Update Posted:
Oct 21, 2014
Last Verified:
Oct 1, 2014