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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dialysis Access Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard balloon angioplasty

Dilatation of stenosis with standard non drug eluting balloon catheter

Group Type ACTIVE_COMPARATOR

Balloon angioplasty (Bard Dorado)

Intervention Type DEVICE

Dilatation of cephalic arch venous stenosis by radial force applied by a balloon catheter

Drug eluting balloon angioplasty

Dilatation of stenosis with paclitaxel eluting balloon catheter

Group Type EXPERIMENTAL

paclitaxel (Cardionovum Legflow drug eluting balloon)

Intervention Type DRUG

Elution of paclitaxel from inflated balloon catheter into vessel wall

Interventions

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paclitaxel (Cardionovum Legflow drug eluting balloon)

Elution of paclitaxel from inflated balloon catheter into vessel wall

Intervention Type DRUG

Balloon angioplasty (Bard Dorado)

Dilatation of cephalic arch venous stenosis by radial force applied by a balloon catheter

Intervention Type DEVICE

Other Intervention Names

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Cardionovum Legflow drug eluting balloon Bard Dorado balloon catheter

Eligibility Criteria

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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