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

Primary Purpose

Renal Failure

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface

PTA alone without use of the GORE VIABAHN

About this trial

This is an interventional treatment trial for Renal Failure focused on measuring Hemodialysis, Fistula, Angiograph, Angiogram

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
The patient experiences angioplasty-induced venous rupture.
The patient has a flow limiting dissection after angioplasty.
The patient's hemodialysis access is thrombosed.

Sites / Locations

Universtiy Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

'PTA without use of the GORE VIABAHN'

PTA with covered stent

Arm Description

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'

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' .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01200914

First Posted

September 10, 2010

Last Updated

May 10, 2016

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT01200914

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Terminated

Why Stopped

poor recruitment

Study Start Date

January 2011 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Failure

Keywords

Hemodialysis, Fistula, Angiograph, Angiogram

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

'PTA without use of the GORE VIABAHN'

Arm Type

Active Comparator

Arm Description

Arm Title

PTA with covered stent

Arm Type

Experimental

Arm Description

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' .

Intervention Type

Device

Intervention Name(s)

GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Other Intervention Name(s)

Covered stent

Intervention Description

The 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' will be deployed at the brachiocephalic stenosis.

Intervention Type

Procedure

Intervention Name(s)

PTA alone without use of the GORE VIABAHN

Intervention Description

Subject will receive standard of care PTA alone at the brachiocephalic stenosis without deployment of the'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface'

Primary Outcome Measure Information:

Title

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. The patient experiences angioplasty-induced venous rupture. The patient has a flow limiting dissection after angioplasty. The patient's hemodialysis access is thrombosed.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dheeraj Rajan, M.D.

Organizational Affiliation

Physician

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universtiy Health Network

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2N2

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

14514859

Citation

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.

Results Reference

background

PubMed Identifier

11877717

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. doi: 10.1067/mva.2002.122025.

Results Reference

background

PubMed Identifier

14712430

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. doi: 10.1053/j.ajkd.2003.09.015.

Results Reference

background

PubMed Identifier

9807560

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. doi: 10.1148/radiology.209.2.9807560.

Results Reference

background

PubMed Identifier

14562971

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. doi: 10.1007/s00270-003-2706-x.

Results Reference

background

PubMed Identifier

10405739

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. doi: 10.1148/radiology.212.1.r99jl21175.

Results Reference

background

PubMed Identifier

15466790

Citation

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.

Results Reference

background

PubMed Identifier

17533532

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. doi: 10.1007/s00270-007-9083-9.

Results Reference

background

PubMed Identifier

18256373

Citation

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.

Results Reference

background

PubMed Identifier

15671353

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. doi: 10.2214/ajr.184.2.01840403.

Results Reference

background

PubMed Identifier

18829240

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.

Results Reference

background

PubMed Identifier

16959720

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. doi: 10.1177/1538574406291803.

Results Reference

background

PubMed Identifier

18503914

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.

Results Reference

background

PubMed Identifier

14717801

Citation

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.

Results Reference

background

PubMed Identifier

9867326

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. doi: 10.1583/1074-6218(1998)0052.0.CO;2.

Results Reference

background

PubMed Identifier

9234140

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. doi: 10.1583/1074-6218(1995)0022.0.CO;2.

Results Reference

background

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

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