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Drug Eluting Balloon Angioplasty for Recurrent Cephalic Arch Stenosis in Dialysis Fistulas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02368197
Recruitment Status : Terminated
First Posted : February 20, 2015
Last Update Posted : July 2, 2018
Information provided by (Responsible Party):
Anthony Verstandig, Shaare Zedek Medical Center

Brief Summary:
This study is designed to compare the safety and efficacy of paclitaxel-eluting balloon (DEB) versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of hemodynamically significant recurrent cephalic arch stenosis in brachial cephalic fistulas in hemodialysis patients.

Condition or disease Intervention/treatment Phase
Dialysis Access Dysfunction Drug: paclitaxel (Cardionovum Legflow drug eluting balloon) Device: Balloon angioplasty (Bard Dorado) Phase 2 Phase 3

Detailed Description:

The cephalic vein constitutes the major outflow conduit for radial- cephalic autogenous accesses and is the sole outflow conduit for brachial- cephalic autogenous accesses. The portion of the cephalic vein that becomes perpendicular in the region of the deltopectoral groove before its confluence with the axillary or subclavian vein,the cephalic arch, is prone to the development of hemodynamically significant stenosis which is usually treated with balloon angioplasty. Unfortunately restenosis due to angioplasty induced intimal hyperplasia is common and periodic repeated angioplasty is necessary to maintain patency.

Paclitaxel is a mitotic inhibitor used in cancer chemotherapy which is used as an antiproliferative agent for the prevention of restenosis (recurrent narrowing) of blood vessels after balloon angioplasty caused by excessive intimal proliferation. It is locally delivered to the wall of the blood vessel during the dilatation using a paclitaxel eluting balloon.

Initial trials with these balloons have shown promising results in peripheral arteries and early encouraging results in dialysis access.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Comparing Drug Eluting Balloon Versus Conventional Balloon Angioplasty for Recurrent Cephalic Arch Stenosis in Dialysis Fistulas.
Study Start Date : July 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Active Comparator: Standard balloon angioplasty
Dilatation of stenosis with standard non drug eluting balloon catheter
Device: Balloon angioplasty (Bard Dorado)
Dilatation of cephalic arch venous stenosis by radial force applied by a balloon catheter
Other Name: Bard Dorado balloon catheter

Experimental: Drug eluting balloon angioplasty
Dilatation of stenosis with paclitaxel eluting balloon catheter
Drug: paclitaxel (Cardionovum Legflow drug eluting balloon)
Elution of paclitaxel from inflated balloon catheter into vessel wall
Other Name: Cardionovum Legflow drug eluting balloon

Primary Outcome Measures :
  1. Restenosis rate [ Time Frame: 6 months ]
    Incidence of >50% stenosis at the treatment site

Secondary Outcome Measures :
  1. Post intervention lesion patency [ Time Frame: Up to 12 months ]
    Interval between intervention and the time of the first subsequent intervention at the treatment site

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Upper limb dialysis access fistula
  • Angiographically demonstrated cephalic arch stenosis >50% within 6 months of last angioplasty using a non drug eluting balloon
  • Clinical evidence of hemodynamically significant stenosis: strong pulse and weak thrill on physical exam, prolonged bleeding from puncture sites, raised Kt/V, raised dialysis venous pressure

Exclusion Criteria:

  • Contrast allergy
  • Unable to give informed consent
  • Cephalic arch stent or stent graft
  • Life expectancy less then 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02368197

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Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Sponsors and Collaborators
Shaare Zedek Medical Center

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Responsible Party: Anthony Verstandig, Dr, Shaare Zedek Medical Center Identifier: NCT02368197     History of Changes
Other Study ID Numbers:
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Keywords provided by Anthony Verstandig, Shaare Zedek Medical Center:
dialysis fistula
cephalic arch stenosis
balloon angioplasty
drug eluting balloon
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action