Renal FailureNCT01200914
Covered Stents to Treat Hemodialysis Access Stenoses in the Cephalic Arch and Central Veins
A study testing GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface and PTA alone without use of the GORE VIABAHN in people with Renal Failure, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Balloon angioplasty is used to open up a narrowing that forms in hemodialysis fistula. Two areas of particular problems are the terminal portion of the cephalic vein near the shoulder and the central veins in the chest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure
- What is being tested?
- GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface and PTA alone without use of the GORE VIABAHN
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 mature forearm or upper arm access that was created > 2 months before enrollment in study.
- The patient is ≥ 18 years of age.
- The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
- The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements.
- The patient or his/her legal guardian is willing to provide informed consent.
- The patient has lesions that meet the angiographic inclusion / exclusion criteria and induce clinical, hemodynamic or functional abnormality.
Who cannot join
- The patient has a known or suspected systemic infection.
- The patient has a known or suspected infection of the hemodialysis access and / or bacteremia.
- The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (>10 mg per day), cyclosporine, tacrolimus, or cyclophosphamide.
- The patient has known bleeding disorder (e.g., hemophilia or von Willebrand's disease).
- The patient has known sensitivity to heparin.
- The patient is scheduled for a live donor kidney transplant.
Show all 18Show fewer
- The patient is enrolled in another investigational study or another access maintenance trial
- The patient has comorbid conditions that may limit their ability to comply with the follow-up requirements.
- Life expectancy is ≤ 24 months.
- The patient has an untreatable allergy to radiographic contrast material.
- The patient is pregnant.
- In the opinion of the operating physician, the patient's hemodialysis access circuit is unsuitable for endovascular treatment.
- The patient's access is planned to be abandoned within 1 year.
- The patient has indwelling catheters (dialysis, pacemakers, ports).
- The patient has a central vein stent that would lead to jailing of the internal jugular vein.
- The patient experiences angioplasty-induced venous rupture.
- The patient has a flow limiting dissection after angioplasty.
- The patient's hemodialysis access is thrombosed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placement of Covered Stents to Treat Hemodialysis Access Stenosis in the Cephalic Arch and Central Veins
Balloon angioplasty is used to open up a narrowing that forms in hemodialysis fistula. Two areas of particular problems are the terminal portion of the cephalic vein near the shoulder and the central veins in the chest. Although angioplasty is standard of care the treated narrowed segments of vein mostly renarrow within 3 months requiring retreatment to keep your dialysis access functional. Recently there has been introduction of a new technology called a covered stent graft. Initial studies suggest that placing this device across the area of narrowing leads to dialysis access staying open longer and needing less angioplasty treatments.
This study is designed to compare angioplasty (standard of care) versus using a covered stent graft. The investigators will then look at the dialysis records and future fistulograms to see if there is decreased flow through the fistula at 3, 6 and 12 months after the initial procedure.
Read the detailed description
This is a randomized, prospective, unblinded study with 1:1 randomization. Both groups will undergo PTA of stenotic lesion and patients will be randomized such that 50% will receive a covered stent in addition to the PTA. Patients will be followed at 3, 6, and 12 months post-procedure. Follow-up will be conducted with either angiographic and/or transonic measurements.
- Conditions
- Renal Failure
- Being tested
- GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface, PTA alone without use of the GORE VIABAHN
- Keywords
- Hemodialysis, Fistula, Angiograph, Angiogram
- Medical subject headings
- Renal Insufficiency, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE VIABAHN® Endoprosthesis with Heparin Bioactive SurfaceDevice
Also called Covered stent
The 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' will be deployed at the brachiocephalic stenosis.
PTA alone without use of the GORE VIABAHNProcedure or surgery
Subject will receive standard of care PTA alone at the brachiocephalic stenosis without deployment of the'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface'
| Study group | Role | What they receive |
|---|---|---|
| 'PTA without use of the GORE VIABAHN' | Active comparator | Subjects randomized to 'PTA alone without use of the GORE VIABAHN' will receive the standard of care treatment which is Percutaneous Transluminal Angioplasty without the use of the 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' Receives: Procedure: PTA alone without use of the GORE VIABAHN |
| PTA with covered stent | Experimental | Subjects randomized to PTA with covered stent will receive Percutaneous Transluminal Angioplasty followed by the delivery of a 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' . Receives: Device: GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion primary patency at 3, 6, and 12 months
Measured: 1 year
Secondary outcomes (1)
Target lesion secondary patency at 3, 6, and 12 months, access circuit primary and secondary patency at 3, 6, and 12 months, anatomic, clinical, and procedural success. Adverse events through 1 month
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startJan 2011
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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 University Health Network, TorontoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dheeraj Rajan, University Health Network, Toronto
- Investigators
- Dheeraj Rajan, M.D., Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200914
- Sponsor's protocol ID
- GORE-001
- Status last verified
- May 2016
- First submitted
- 10 Sep 2010
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gray RJ, Sacks D, Martin LG, Trerotola SO; Society of Interventional Radiology Technology Assessment Committee. Reporting standards for percutaneous interventions in dialysis access. J Vasc Interv Radiol. 2003 Sep;14(9 Pt 2):S433-42. doi: 10.1097/01.rvi.0000094618.61428.58. No abstract available.
PubMed 14514859Sidawy AN, Gray R, Besarab A, Henry M, Ascher E, Silva M Jr, Miller A, Scher L, Trerotola S, Gregory RT, Rutherford RB, Kent KC. Recommended standards for reports dealing with arteriovenous hemodialysis accesses. J Vasc Surg. 2002 Mar;35(3):603-10. doi: 10.1067/mva.2002.122025.
PubMed 11877717Chang CJ, Ko PJ, Hsu LA, Ko YS, Ko YL, Chen CF, Huang CC, Hsu TS, Lee YS, Pang JH. Highly increased cell proliferation activity in the restenotic hemodialysis vascular access after percutaneous transluminal angioplasty: implication in prevention of restenosis. Am J Kidney Dis. 2004 Jan;43(1):74-84. doi: 10.1053/j.ajkd.2003.09.015.
PubMed 14712430Patel RI, Peck SH, Cooper SG, Epstein DM, Sofocleous CT, Schur I, Falk A. Patency of Wallstents placed across the venous anastomosis of hemodialysis grafts after percutaneous recanalization. Radiology. 1998 Nov;209(2):365-70. doi: 10.1148/radiology.209.2.9807560.
PubMed 9807560Rajan DK, Clark TW. Patency of Wallstents placed at the venous anastomosis of dialysis grafts for salvage of angioplasty-induced rupture. Cardiovasc Intervent Radiol. 2003 May-Jun;26(3):242-5. doi: 10.1007/s00270-003-2706-x.
PubMed 14562971Haage P, Vorwerk D, Piroth W, Schuermann K, Guenther RW. Treatment of hemodialysis-related central venous stenosis or occlusion: results of primary Wallstent placement and follow-up in 50 patients. Radiology. 1999 Jul;212(1):175-80. doi: 10.1148/radiology.212.1.r99jl21175.
PubMed 10405739Vogel PM, Parise C. SMART stent for salvage of hemodialysis access grafts. J Vasc Interv Radiol. 2004 Oct;15(10):1051-60. doi: 10.1097/01.RVI.0000129915.48500.DC.
PubMed 15466790Rajan DK, Saluja JS. Use of nitinol stents following recanalization of central venous occlusions in hemodialysis patients. Cardiovasc Intervent Radiol. 2007 Jul-Aug;30(4):662-7. doi: 10.1007/s00270-007-9083-9.
PubMed 17533532Chan MR, Bedi S, Sanchez RJ, Young HN, Becker YT, Kellerman PS, Yevzlin AS. Stent placement versus angioplasty improves patency of arteriovenous grafts and blood flow of arteriovenous fistulae. Clin J Am Soc Nephrol. 2008 May;3(3):699-705. doi: 10.2215/CJN.04831107. Epub 2008 Feb 6.
PubMed 18256373Pan HB, Liang HL, Lin YH, Chung HM, Wu TH, Chen CY, Fang HC, Chen CK, Lai PH, Yang CF. Metallic stent placement for treating peripheral outflow lesions in native arteriovenous fistula hemodialysis patients after insufficient balloon dilatation. AJR Am J Roentgenol. 2005 Feb;184(2):403-9. doi: 10.2214/ajr.184.2.01840403.
PubMed 15671353Shemesh D, Goldin I, Zaghal I, Berlowitz D, Raveh D, Olsha O. Angioplasty with stent graft versus bare stent for recurrent cephalic arch stenosis in autogenous arteriovenous access for hemodialysis: a prospective randomized clinical trial. J Vasc Surg. 2008 Dec;48(6):1524-31, 1531.e1-2. doi: 10.1016/j.jvs.2008.07.071. Epub 2008 Oct 1.
PubMed 18829240Naoum JJ, Irwin C, Hunter GC. The use of covered nitinol stents to salvage dialysis grafts after multiple failures. Vasc Endovascular Surg. 2006 Aug-Sep;40(4):275-9. doi: 10.1177/1538574406291803.
PubMed 16959720Gupta M, Rajan DK, Tan KT, Sniderman KW, Simons ME. Use of expanded polytetrafluoroethylene-covered nitinol stents for the salvage of dysfunctional autogenous hemodialysis fistulas. J Vasc Interv Radiol. 2008 Jun;19(6):950-4. doi: 10.1016/j.jvir.2008.03.016. Epub 2008 Apr 28.
PubMed 18503914Clark TW, Rajan DK. Treating intractable venous stenosis: present and future therapy. Semin Dial. 2004 Jan-Feb;17(1):4-8. doi: 10.1111/j.1525-139x.2004.17103.x.
PubMed 14717801Yuan JG, Ohki T, Marin ML, Quintos RT, Krohn DL, Beitler JJ, Veith FJ. The effect of nonporous PTFE-covered stents on intimal hyperplasia following balloon arterial injury in minipigs. J Endovasc Surg. 1998 Nov;5(4):349-58. doi: 10.1583/1074-6218(1998)0052.0.CO;2.
PubMed 9867326
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placement of Covered Stents to Treat Hemodialysis Access Stenosis in the Cephalic Arch and Central Veins
- ClinicalTrials.gov ID
- NCT01200914
- Acronym / sponsor ID
- GORE-001
- Conditions
- Renal Failure
- Keywords
- Hemodialysis, Fistula, Angiograph, Angiogram
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 14 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Balloon angioplasty is used to open up a narrowing that forms in hemodialysis fistula. Two areas of particular problems are the terminal portion of the cephalic vein near the shoulder and the central veins in the chest. Although angioplasty is standard of care the treated narrowed segments of vein mostly renarrow within 3 months requiring retreatment to keep your dialysis access functional. Recently there has been introduction of a new technology called a covered stent graft. Initial studies suggest that placing this device across the area of narrowing leads to dialysis access staying open longer and needing less angioplasty treatments.
This study is designed to compare angioplasty (standard of care) versus using a covered stent graft. The investigators will then look at the dialysis records and future fistulograms to see if there is decreased flow through the fistula at 3, 6 and 12 months after the initial procedure.
Detailed description
This is a randomized, prospective, unblinded study with 1:1 randomization. Both groups will undergo PTA of stenotic lesion and patients will be randomized such that 50% will receive a covered stent in addition to the PTA. Patients will be followed at 3, 6, and 12 months post-procedure. Follow-up will be conducted with either angiographic and/or transonic measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'PTA without use of the GORE VIABAHN' | Active comparator | Procedure: PTA alone without use of the GORE VIABAHNSubjects randomized to 'PTA alone without use of the GORE VIABAHN' will receive the standard of care treatment which is Percutaneous Transluminal Angioplasty without the use of the 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' |
| PTA with covered stent | Experimental | Device: GORE VIABAHN® Endoprosthesis with Heparin Bioactive SurfaceSubjects randomized to PTA with covered stent will receive Percutaneous Transluminal Angioplasty followed by the delivery of a 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hemodialysis patient with a mature forearm or upper arm access that was created > 2 months before enrollment in study.
- The patient is ≥ 18 years of age.
- The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
- The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements.
- The patient or his/her legal guardian is willing to provide informed consent.
Key exclusion criteria (18 listed)
- The patient has a known or suspected systemic infection.
- The patient has a known or suspected infection of the hemodialysis access and / or bacteremia.
- The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (>10 mg per day), cyclosporine, tacrolimus, or cyclophosphamide.
- The patient has known bleeding disorder (e.g., hemophilia or von Willebrand's disease).
- The patient has known sensitivity to heparin.
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 Heparin Bioactive SurfaceAlso: Covered stentThe 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' will be deployed at the brachiocephalic stenosis. | Device | PTA with covered stent |
| PTA alone without use of the GORE VIABAHNSubject will receive standard of care PTA alone at the brachiocephalic stenosis without deployment of the'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' | Procedure or surgery | 'PTA without use of the GORE VIABAHN' |
Primary outcome
Target lesion primary patency at 3, 6, and 12 months
Time frame: 1 year
1 secondary outcome
Target lesion secondary patency at 3, 6, and 12 months, access circuit primary and secondary patency at 3, 6, and 12 months, anatomic, clinical, and procedural success. Adverse events through 1 month
Time frame: 1 year
Results and safety
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Background: PubMed 14514859Gray RJ, Sacks D, Martin LG, Trerotola SO; Society of Interventional Radiology Technology Assessment Committee. Reporting standards for percutaneous interventions in dialysis access. J Vasc Interv Radiol. 2003 Sep;14(9 Pt 2):S433-42. doi: 10.1097/01.rvi.0000094618.61428.58. No abstract available.
- Background: PubMed 11877717Sidawy AN, Gray R, Besarab A, Henry M, Ascher E, Silva M Jr, Miller A, Scher L, Trerotola S, Gregory RT, Rutherford RB, Kent KC. Recommended standards for reports dealing with arteriovenous hemodialysis accesses. J Vasc Surg. 2002 Mar;35(3):603-10. doi: 10.1067/mva.2002.122025.
- Background: PubMed 14712430Chang CJ, Ko PJ, Hsu LA, Ko YS, Ko YL, Chen CF, Huang CC, Hsu TS, Lee YS, Pang JH. Highly increased cell proliferation activity in the restenotic hemodialysis vascular access after percutaneous transluminal angioplasty: implication in prevention of restenosis. Am J Kidney Dis. 2004 Jan;43(1):74-84. doi: 10.1053/j.ajkd.2003.09.015.
- Background: PubMed 9807560Patel RI, Peck SH, Cooper SG, Epstein DM, Sofocleous CT, Schur I, Falk A. Patency of Wallstents placed across the venous anastomosis of hemodialysis grafts after percutaneous recanalization. Radiology. 1998 Nov;209(2):365-70. doi: 10.1148/radiology.209.2.9807560.
- Background: PubMed 14562971Rajan DK, Clark TW. Patency of Wallstents placed at the venous anastomosis of dialysis grafts for salvage of angioplasty-induced rupture. Cardiovasc Intervent Radiol. 2003 May-Jun;26(3):242-5. doi: 10.1007/s00270-003-2706-x.
- Background: PubMed 10405739Haage P, Vorwerk D, Piroth W, Schuermann K, Guenther RW. Treatment of hemodialysis-related central venous stenosis or occlusion: results of primary Wallstent placement and follow-up in 50 patients. Radiology. 1999 Jul;212(1):175-80. doi: 10.1148/radiology.212.1.r99jl21175.
- Background: PubMed 15466790Vogel PM, Parise C. SMART stent for salvage of hemodialysis access grafts. J Vasc Interv Radiol. 2004 Oct;15(10):1051-60. doi: 10.1097/01.RVI.0000129915.48500.DC.
- Background: PubMed 17533532Rajan DK, Saluja JS. Use of nitinol stents following recanalization of central venous occlusions in hemodialysis patients. Cardiovasc Intervent Radiol. 2007 Jul-Aug;30(4):662-7. doi: 10.1007/s00270-007-9083-9.
- Background: PubMed 18256373Chan MR, Bedi S, Sanchez RJ, Young HN, Becker YT, Kellerman PS, Yevzlin AS. Stent placement versus angioplasty improves patency of arteriovenous grafts and blood flow of arteriovenous fistulae. Clin J Am Soc Nephrol. 2008 May;3(3):699-705. doi: 10.2215/CJN.04831107. Epub 2008 Feb 6.
- Background: PubMed 15671353Pan HB, Liang HL, Lin YH, Chung HM, Wu TH, Chen CY, Fang HC, Chen CK, Lai PH, Yang CF. Metallic stent placement for treating peripheral outflow lesions in native arteriovenous fistula hemodialysis patients after insufficient balloon dilatation. AJR Am J Roentgenol. 2005 Feb;184(2):403-9. doi: 10.2214/ajr.184.2.01840403.
- Background: PubMed 18829240Shemesh D, Goldin I, Zaghal I, Berlowitz D, Raveh D, Olsha O. Angioplasty with stent graft versus bare stent for recurrent cephalic arch stenosis in autogenous arteriovenous access for hemodialysis: a prospective randomized clinical trial. J Vasc Surg. 2008 Dec;48(6):1524-31, 1531.e1-2. doi: 10.1016/j.jvs.2008.07.071. Epub 2008 Oct 1.
- Background: PubMed 16959720Naoum JJ, Irwin C, Hunter GC. The use of covered nitinol stents to salvage dialysis grafts after multiple failures. Vasc Endovascular Surg. 2006 Aug-Sep;40(4):275-9. doi: 10.1177/1538574406291803.
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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.
Dheeraj Rajan, M.D. principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface and PTA alone without use of the GORE VIABAHN in people with Renal Failure, run by University Health Network, Toronto at 1 site in Canada.
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 6 inclusion and 18 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: stopped early, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
Are results available for this study?
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
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 3, 6, and 12 months (time frame: 1 year). 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 NCT01200914, which also lists 16 linked publications.
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 12 May 2016.