HemodialysisNCT01271881
Placement of Covered Stents to Treat Hemodialysis Access Stenoses in the Cephalic Arch and Central Veins
A study testing PTA alone without use of the GORE VIABAHN and GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface in people with Hemodialysis, run by American Access Care at 3 sites in United States.
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 to 70 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- PTA alone without use of the GORE VIABAHN and GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2010to Oct 2011
- 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 to 70 years
- 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
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
American Access Care of Queens
Flushing, New York, 11366
Kiran Jotwani, MD, 718-820-9729
Kiran Jotwani, MD
- Recruiting
American Access Care of Bronx
The Bronx, New York, 10461
Abigail Falk, Dr., 718-794-9729, abigailfalk123@pol.net
Abigail Falk, Dr.
- Recruiting
Access Care Physicians of New York
White Plains, New York, 10601
Claudio Cantu, RPA, 914-683-9729, CCacntu@aac-llc.com
Claudio Cantu, RPA
About this study
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.
- Conditions
- Hemodialysis
- Being tested
- PTA alone without use of the GORE VIABAHN, GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface
- Keywords
- Hemodialysis, Fistula, Angiograph, Angiogram, Adult patients who are currently receiving hemodialysis treatment via an AV vascular graft or fistula located in the upper extremity
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTA alone without use of the GORE VIABAHNOther
PTA alone with no stent used
GORE VIABAHN® Endoprosthesis with Heparin Bioactive SurfaceDevice
Also called Covered stent
Covered stent produced by GORE VIABAHN
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Transluminal Angioplasty (PTA) alone | Active comparator | Intervention: Procedure: PTA alone without use of the GORE VIABAHN Receives: Other: PTA alone without use of the GORE VIABAHN |
| PTA with covered stent | Experimental | 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.
Primary patency at 3, 6, and 12 months
Target lesion primary patency at 3, 6, and 12 months
Measured: 1 year
Secondary outcomes (1)
Secondary patency at 3, 6, and 12 months
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 posted7 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2011 (estimated)
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 HemodialysisStudies of the same condition, open and under way.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Access Care
- Sponsor type
- University, hospital or other
- Investigators
- Abigail Falk, Dr., Principal investigator, American Access Care PhysicianClaudio Cantu, RPA, Study chair, American Access Care Center Operations Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271881
- Sponsor's protocol ID
- GORE-01
- Status last verified
- Jan 2011
- First submitted
- 1 Dec 2010
- Last updated
- 7 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gray RJ, Sacks D, Martin LG, Trerotola SO. Reporting standards for percutaneous interventions in dialysis access. Technology Assessment Committee. J Vasc Interv Radiol. 1999 Nov-Dec;10(10):1405-15. doi: 10.1016/s1051-0443(99)70252-6. No abstract available.
PubMed 10584659Sidawy 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 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placement of Covered Stents to Treat Hemodialysis Access Stenoses in the Cephalic Arch and Central Veins
- ClinicalTrials.gov ID
- NCT01271881
- Acronym / sponsor ID
- GORE-01
- Conditions
- Hemodialysis
- Keywords
- Hemodialysis, Fistula, Angiograph, Angiogram, Adult patients who are currently receiving hemodialysis treatment via an AV vascular graft or fistula located in the upper extremity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- American Access CareUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (estimated)
- First posted
- 7 Jan 2011 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Transluminal Angioplasty (PTA) alone | Active comparator | Other: PTA alone without use of the GORE VIABAHNIntervention: Procedure: PTA alone without use of the GORE VIABAHN |
| PTA with covered stent | Experimental | Device: GORE VIABAHN® Endoprosthesis with Heparin Bioactive SurfaceGORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface |
Who may qualify
- Ages
- 18 to 70 years
- 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 |
|---|---|---|
| PTA alone without use of the GORE VIABAHNPTA alone with no stent used | Other | Percutaneous Transluminal Angioplasty (PTA) alone |
| GORE VIABAHN® Endoprosthesis with Heparin Bioactive SurfaceAlso: Covered stentCovered stent produced by GORE VIABAHN | Device | PTA with covered stent |
Primary outcome
Primary patency at 3, 6, and 12 months
Time frame: 1 year
Target lesion primary patency at 3, 6, and 12 months
1 secondary outcome
Secondary patency at 3, 6, and 12 months
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2011.
- Background: PubMed 10584659Gray RJ, Sacks D, Martin LG, Trerotola SO. Reporting standards for percutaneous interventions in dialysis access. Technology Assessment Committee. J Vasc Interv Radiol. 1999 Nov-Dec;10(10):1405-15. doi: 10.1016/s1051-0443(99)70252-6. 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.
- AngioplastyLink provided by the sponsor.
- DialysisLink provided by the sponsor.
- FistulasLink provided by the sponsor.
- Kidney FailureLink provided by the sponsor.
- HeparinLink provided by the sponsor.
Related trials for Hemodialysis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
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.
Abigail Falk, Dr. principal investigator
American Access Care Physician
Claudio Cantu, RPA study chair
American Access Care Center Operations Manager
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTA alone without use of the GORE VIABAHN and GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface in people with Hemodialysis, run by American Access Care at 3 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 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: status not confirmed, as of the sponsor's last update on 7 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abigail Falk, Dr. (914-683-9731, abigailfalk123@pol.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 NCT01271881, 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 7 Jan 2011.