Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

Summary

The purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon.

Timeline

Start

2011-12

Primary completion

2013-12

Completion

2014-07

Outcome

Met primary endpoint

paper in-segment LLL was 0.48 ± 0.51 mm in the uncoated SB group versus 0.17 ± 0.40 mm in the drug-coated SB group (P = 0.01; ITT analysis). PMID 26331782 ↗

Publications

• Scheller B, Fontaine T, Mangner N, Hoffmann S, Bonaventura K, Clever YP, Chamie D, Costa R, Gershony G, Kelsch B, Kutschera M, Genereux P, Cremers B, Bohm M, Speck U, Abizaid A. A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial. Catheter Cardiovasc Interv. 2016 Jul;88(1):51-9. doi: 10.1002/ccd.26216. Epub 2015 Sep 2.

Drugs

Indications