Phase 3
N=293
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
Renal Failure · Hemodialysis
Bottom Line
View on ClinicalTrials.gov: NCT00737672 ↗Enrolled (actual)
293
Serious AEs
52.9%
Results posted
Oct 2014
Primary outcome: Primary: Target Lesion Primary Patency at 6 Months — 52.9; 35.5 Percentage of Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface (Device); Percutaneous Transluminal Angioplasty (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- W.L.Gore & Associates
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Target Lesion Primary Patency at 6 Months |
52.9; 35.5 | — |
| PRIMARY Target Lesion Primary Patency at 12 Months |
30.2; 18.2 | — |
| PRIMARY Target Lesion Primary Patency at 24 Months |
15.7; 9.9 | 0.008 sig |
| PRIMARY Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure |
0; 2 | <0.001 sig |
| SECONDARY Assisted Primary Patency at 6 Months |
56.2; 51.1 | 0.530 |
| SECONDARY Assisted Primary Patency at 12 Months |
43.5; 35.3 | — |
| SECONDARY Assisted Primary Patency at 24 Months |
29.2; 29.0 | — |
| SECONDARY Access Secondary Patency at 6 Months |
91.2; 86.5 | 0.475 |
| SECONDARY Access Secondary Patency [12 Months] Units Percentage of Subjects |
82.7; 78.6 | — |
| SECONDARY Access Secondary Patency [24 Months] Units Percentage of Subjects |
68.9; 66.6 | — |
| SECONDARY Circuit Primary Patency |
43.4; 29.4 | 0.035 sig |
| SECONDARY Circuit Primary Patency [12 Months] Units Percentage of Subjects |
21.4; 15.2 | — |
| SECONDARY Circuit Primary Patency [24 Months] Units Percentage of Subjects |
9.6; 6.8 | — |
| SECONDARY Clinical Success |
128; 135; 3; 3 | 1.000 |
| SECONDARY Anatomic Success |
131; 116; 0; 22 | <0.001 sig |
| SECONDARY Procedural Success |
128; 113; 3; 25 | <0.001 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00737672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.