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

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01271881
• Other study ID #: GORE-01
• Status: Recruiting
• Phase: N/A
• First received: December 1, 2010
• Last updated: January 6, 2011
• Start date: October 2010

Study information

• Verified date: January 2011
• Source: American Access Care
• Contact: Abigail Falk, Dr.
• Phone: 914-683-9731
• Email: abigailfalk123[@]pol.net
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Hemodialysis patient with a mature forearm or upper arm access that was created > 2 months before enrollment in study.

2. The patient is = 18 years of age.

3. The patient has a reasonable expectation of remaining on hemodialysis for 12 months.

4. The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements.

5. The patient or his/her legal guardian is willing to provide informed consent.

6. The patient has lesions that meet the angiographic inclusion / exclusion criteria and induce clinical, hemodynamic or functional abnormality.

Exclusion Criteria:

1. The patient has a known or suspected systemic infection.

2. The patient has a known or suspected infection of the hemodialysis access and / or bacteremia.

3. The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (>10 mg per day), cyclosporine, tacrolimus, or cyclophosphamide.

4. The patient has known bleeding disorder (e.g., hemophilia or von Willebrand's disease).

5. The patient has known sensitivity to heparin.

6. The patient is scheduled for a live donor kidney transplant.

7. The patient is enrolled in another investigational study or another access maintenance trial

8. The patient has comorbid conditions that may limit their ability to comply with the follow-up requirements

9. Life expectancy is = 24 months.

10. The patient has an untreatable allergy to radiographic contrast material.

11. The patient is pregnant.

12. In the opinion of the operating physician, the patient's hemodialysis access circuit is unsuitable for endovascular treatment.

13. The patient's access is planned to be abandoned within 1 year.

14. The patient has indwelling catheters (dialysis, pacemakers, ports).

15. The patient has a central vein stent that would lead to jailing of the internal jugular vein.

16. The patient experiences angioplasty-induced venous rupture.

17. The patient has a flow limiting dissection after angioplasty.

18. The patient's hemodialysis access is thrombosed.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Other:
• PTA alone without use of the GORE VIABAHN
PTA alone with no stent used

Device:
• GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Covered stent produced by GORE VIABAHN

Locations

Country	Name	City	State
United States	American Access Care of Bronx	Bronx	New York
United States	American Access Care of Queens	Flushing	New York
United States	Access Care Physicians of New York	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
American Access Care

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

Clark TW, Rajan DK. Treating intractable venous stenosis: present and future therapy. Semin Dial. 2004 Jan-Feb;17(1):4-8. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Vogel PM, Parise C. SMART stent for salvage of hemodialysis access grafts. J Vasc Interv Radiol. 2004 Oct;15(10):1051-60. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency at 3, 6, and 12 months	Target lesion primary patency at 3, 6, and 12 months	1 year	No
Secondary	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	1 year	No

External Links

•   Angioplasty
•   Dialysis
•   Fistulas
•   Heparin
•   Kidney Failure