Placement of Covered Stents to Treat Hemodialysis Access Stenoses in the Cephalic Arch and Central Veins

NCT01271881 | Unknown DMC

• 1 other identifier: GORE-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

Brief 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. 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

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

Outcome Measures

Primary Outcomes (1)

• Primary patency at 3, 6, and 12 months

  Target lesion primary patency at 3, 6, and 12 months

  1 year

Secondary Outcomes (1)

• Secondary patency at 3, 6, and 12 months

  1 year

Study Arms (2)

Percutaneous Transluminal Angioplasty (PTA) alone

ACTIVE COMPARATOR

Intervention: Procedure: PTA alone without use of the GORE VIABAHN

Other: PTA alone without use of the GORE VIABAHN

PTA with covered stent

EXPERIMENTAL

GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Device: GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Interventions

PTA alone without use of the GORE VIABAHN OTHER

PTA alone with no stent used

Percutaneous Transluminal Angioplasty (PTA) alone

GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface DEVICE

Covered stent produced by GORE VIABAHN

Also known as: Covered stent

PTA with covered stent

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• American Access Care: lead

Study Sites (3)

American Access Care of Queens

Flushing, New York, 11366, United States

RECRUITING

American Access Care of Bronx

The Bronx, New York, 10461, United States

RECRUITING

Access Care Physicians of New York

White Plains, New York, 10601, United States

RECRUITING

Related Publications (16)

• 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.

  PMID: 10584659 BACKGROUND

• Sidawy 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.

  PMID: 11877717 BACKGROUND

• Chang 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.

  PMID: 14712430 BACKGROUND

• Patel 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.

  PMID: 9807560 BACKGROUND

• Rajan 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.

  PMID: 14562971 BACKGROUND

• Haage 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.

  PMID: 10405739 BACKGROUND

• Vogel 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.

  PMID: 15466790 BACKGROUND

• Rajan 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.

  PMID: 17533532 BACKGROUND

• Chan 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.

  PMID: 18256373 BACKGROUND

• Pan 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.

  PMID: 15671353 BACKGROUND

• Shemesh 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.

  PMID: 18829240 BACKGROUND

• Naoum 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.

  PMID: 16959720 BACKGROUND

• Gupta 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.

  PMID: 18503914 BACKGROUND

• Clark 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.

  PMID: 14717801 BACKGROUND

• Yuan 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.

  PMID: 9867326 BACKGROUND

• Fontaine AB, Dos Passos S, Spigos D, Cearlock J, Urbaneja A. Use of polyetherurethane to improve the biocompatibility of vascular stents. J Endovasc Surg. 1995 Aug;2(3):255-65. doi: 10.1583/1074-6218(1995)0022.0.CO;2.

  PMID: 9234140 BACKGROUND

Related Links

• Angioplasty
• Dialysis
• Fistulas
• Kidney Failure
• Heparin

MeSH Terms

Conditions

Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Abigail Falk, Dr.

  American Access Care Physician

  PRINCIPAL INVESTIGATOR

• Claudio Cantu, RPA

  American Access Care Center Operations Manager

  STUDY CHAIR

Central Study Contacts

Abigail Falk, Dr.

CONTACT

914-683-9731; abigailfalk123@pol.net

Claudio Cantu, RPA

CONTACT

914-683-9729; CCantu@aac-llc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: January 7, 2011
• Study Start: October 1, 2010
• Primary Completion: October 1, 2011
• Last Updated: January 7, 2011

Record last verified: 2011-01

Locations

US (3)