Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae

Summary

This prospective, global, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.

Timeline

Start

2015-06

Primary completion

2016-09

Completion

2018-06

Outcome

Mixed primary results

paper The 180-day end point was not met with target lesion primary patency (71%±4% for the drug-coated balloon and 63%±4% for control; P=0.06), PMID 30042225 ↗

paper The primary safety noninferiority end point was met and did not differ between groups (P=0.002). PMID 30042225 ↗

Publications

• Trerotola SO, Lawson J, Roy-Chaudhury P, Saad TF; Lutonix AV Clinical Trial Investigators. Drug Coated Balloon Angioplasty in Failing AV Fistulas: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2018 Aug 7;13(8):1215-1224. doi: 10.2215/CJN.14231217. Epub 2018 Jul 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paclitaxel	Small molecule	—	—

Indications