NCT02368197

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

Prospective Randomized Trial Comparing Drug Eluting Balloon Versus Conventional Balloon Angioplasty for Recurrent Cephalic Arch Stenosis in Dialysis Fistulas.

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dialysis Access Dysfunction

Interventions

Type	Name	Description
DRUG	paclitaxel (Cardionovum Legflow drug eluting balloon)	Elution of paclitaxel from inflated balloon catheter into vessel wall
DEVICE	Balloon angioplasty (Bard Dorado)	Dilatation of cephalic arch venous stenosis by radial force applied by a balloon catheter

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-05-01
• Completion: 2017-12-01
• First posted: 2015-02-20
• Last updated: 2018-07-02

Locations

1 site across 1 country: Israel