Renal FailurePhase 3REVISENCT00737672
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
A Phase 3 study testing GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface and Percutaneous Transluminal Angioplasty in people with Renal Failure and Hemodialysis, run by W.L.Gore & Associates at 31 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Hemodialysis
- What is being tested?
- GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface and Percutaneous Transluminal Angioplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 31 sitesUnited States
- Study dates
- Sep 2008to Jun 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Study site
Albany, Georgia, 31707-1908
Study site
Baltimore, Maryland, 21239
Study site
Beaumont, Texas, 77701
Study site
Bellevue, Washington, 98004
Study site
Birmingham, Alabama, 35249
Study site
Charleston, South Carolina, 29421
Study site
Chicago, Illinois, 60612-3833
Study site
Cincinnati, Ohio, 45212
Study site
Cincinnati, Ohio, 45267-0585
Study site
Dayton, Ohio, 45406
Study site
Des Moines, Iowa, 50309
Study site
Fresno, California, 93710
Study site
Greenville, South Carolina, 29615
Study site
Houston, Texas, 77030
Study site
Inglewood, California, 90301
Study site
Jacksonville, Florida, 32209
Study site
Louisville, Kentucky, 40202
Study site
Milwaukee, Wisconsin, 53226
Study site
New Brighton, Minnesota, 55112
Study site
New Haven, Connecticut, 06520
Study site
Norfolk, Virginia, 23507
Study site
Oceanside, California, 92056
Study site
Philadelphia, Pennsylvania, 19104
Study site
Portland, Oregon, 97210
Study site
Riverside, California, 92501
Study site
Saint Paul, Minnesota, 55101
Study site
San Diego, California, 92115
Study site
San Diego, California, 92120
Study site
San Francisco, California, 94143
Study site
Spokane, Washington, 99204
Study site
Winchester, Virginia, 22601
About this study
Official title: GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients
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.
Read the 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.
- Conditions
- Renal Failure, Hemodialysis
- Being tested
- GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface, Percutaneous Transluminal Angioplasty
- Keywords
- Hemodialysis, Stent Graft, Venous Anastomosis, Arteriovenous Grafts
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive SurfaceDevice
Deployment of investigational stent graft at the venous anastomosis
Percutaneous Transluminal AngioplastyProcedure or surgery
Percutaneous Transluminal Angioplasty at the venous anastomosis
| Study group | Role | What they receive |
|---|---|---|
| VIABAHN Treatment Group | Experimental | 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 Receives: Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface |
| PTA Treatment Group | Active comparator | 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 Receives: Procedure: Percutaneous Transluminal Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Primary Patency at 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.
Measured: 6 months
Target Lesion Primary Patency at 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.
Measured: 12 Months
Target Lesion Primary Patency at 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.
Measured: 24 Months
Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure
The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.
Measured: 30 days
Secondary outcomes (12)
Assisted Primary Patency at 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.
Measured: 6 months
Assisted Primary Patency at 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.
Measured: 12 months
Assisted Primary Patency at 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.
Measured: 24 months
Access Secondary Patency at 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.
Measured: 6 months
Access Secondary Patency [12 Months] Units Percentage of Subjects
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.
Measured: 12 months
Access Secondary Patency [24 Months] Units Percentage of Subjects
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.
Measured: 24 months
Circuit Primary Patency
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.
Measured: 6 months
Circuit Primary Patency [12 Months] Units Percentage of Subjects
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.
Measured: 12months
Circuit Primary Patency [24 Months] Units Percentage of Subjects
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.
Measured: 24 months
Clinical Success
The resumption of normal dialysis for at least one session following study treatment (Index Procedure).
Measured: Following Index Procedure
Anatomic Success
Less than 30 percent residual stenosis following study treatment (Index Procedure).
Measured: Index Procedure
Procedural Success
Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.
Measured: Following Index Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2011
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Vesely, MD, Study director, Vascular Access Center; Frontenac, MO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737672
- Sponsor's protocol ID
- AVR 06-01
- Other IDs
- G070069
- Acronym
- REVISE
- Status last verified
- Oct 2014
- First submitted
- 15 Aug 2008
- Last updated
- 21 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mohr BA, Sheen AL, Roy-Chaudhury P, Schultz SR, Aruny JE; REVISE Investigators. Clinical and Economic Benefits of Stent Grafts in Dysfunctional and Thrombosed Hemodialysis Access Graft Circuits in the REVISE Randomized Trial. J Vasc Interv Radiol. 2019 Feb;30(2):203-211.e4. doi: 10.1016/j.jvir.2018.12.006.
PubMed 30717951
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00737672
- Acronym / sponsor ID
- REVISE / AVR 06-01
- Conditions
- Renal Failure, Hemodialysis
- Keywords
- Hemodialysis, Stent Graft, Venous Anastomosis, Arteriovenous Grafts
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Aug 2008 (estimated)
- Results
- Posted 21 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIABAHN Treatment Group | Experimental | Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive SurfaceUse 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 |
| PTA Treatment Group | Active comparator | Procedure: Percutaneous Transluminal AngioplastyPercutaneous 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GORE VIABAHN Endoprosthesis with PROPATEN Bioactive SurfaceDeployment of investigational stent graft at the venous anastomosis | Device | VIABAHN Treatment Group |
| Percutaneous Transluminal AngioplastyPercutaneous Transluminal Angioplasty at the venous anastomosis | Procedure or surgery | PTA Treatment Group |
Primary outcome
Target Lesion Primary Patency at 6 Months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 30 days
The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.
12 secondary outcomes
Assisted Primary Patency at 6 Months
Time frame: 6 months
Assisted Primary Patency at 12 Months
Time frame: 12 months
Assisted Primary Patency at 24 Months
Time frame: 24 months
Access Secondary Patency at 6 Months
Time frame: 6 months
Access Secondary Patency [12 Months] Units Percentage of Subjects
Time frame: 12 months
Access Secondary Patency [24 Months] Units Percentage of Subjects
Time frame: 24 months
Circuit Primary Patency
Time frame: 6 months
Circuit Primary Patency [12 Months] Units Percentage of Subjects
Time frame: 12months
Circuit Primary Patency [24 Months] Units Percentage of Subjects
Time frame: 24 months
Clinical Success
Time frame: Following Index Procedure
Anatomic Success
Time frame: Index Procedure
Procedural Success
Time frame: Following Index Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30717951Mohr BA, Sheen AL, Roy-Chaudhury P, Schultz SR, Aruny JE; REVISE Investigators. Clinical and Economic Benefits of Stent Grafts in Dysfunctional and Thrombosed Hemodialysis Access Graft Circuits in the REVISE Randomized Trial. J Vasc Interv Radiol. 2019 Feb;30(2):203-211.e4. doi: 10.1016/j.jvir.2018.12.006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Vesely, MD study director
Vascular Access Center; Frontenac, MO
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface and Percutaneous Transluminal Angioplasty in people with Renal Failure and Hemodialysis, run by W.L.Gore & Associates at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Primary Patency at 6 Months (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00737672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2014; AzTrials last refreshed its copy on 8 Nov 2026.