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

Phase 2

Terminated

• Conditions: Dialysis Access Dysfunction
• Interventions: Drug: paclitaxel (Cardionovum Legflow drug eluting balloon); Device: Balloon angioplasty (Bard Dorado)

• Registration Number: NCT02368197
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2015-02-19
• Study First Posted: 2015-02-20
• Study Start: 2015-07
• Primary Completion: 2017-05
• Study Completion: 2017-12
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-28
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug eluting balloon angioplasty	paclitaxel (Cardionovum Legflow drug eluting balloon)	Dilatation of stenosis with paclitaxel eluting balloon catheter
Standard balloon angioplasty	Balloon angioplasty (Bard Dorado)	Dilatation of stenosis with standard non drug eluting balloon catheter

Primary Outcome Measures

Name	Time	Method
Restenosis rate	6 months	Incidence of \>50% stenosis at the treatment site

Secondary Outcome Measures

Name	Time	Method
Post intervention lesion patency	Up to 12 months	Interval between intervention and the time of the first subsequent intervention at the treatment site

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel