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

Shaare Zedek Medical Center

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Dialysis Access Dysfunction

Treatments: Drug: paclitaxel (Cardionovum Legflow drug eluting balloon); Device: Balloon angioplasty (Bard Dorado)

Study type: Interventional

Funder types: Other

Identifiers

NCT02368197

DEB.cr.il

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Standard balloon angioplasty

Active Comparator group

Description:

Dilatation of stenosis with standard non drug eluting balloon catheter

Treatment:

Device: Balloon angioplasty (Bard Dorado)

Drug eluting balloon angioplasty

Experimental group

Description:

Dilatation of stenosis with paclitaxel eluting balloon catheter

Treatment:

Drug: paclitaxel (Cardionovum Legflow drug eluting balloon)