Efficacy and safety of novel multi-lumen catheter for chronic total occlusions: From preclinical study to first-in-man experience

Yoshiaki Mitsutake, Adrian Ebner, Alan C. Yeung, Mark D. Taber, Charles J. Davidson, Fumiaki Ikeno*

*Corresponding author for this work

Research output: Contribution to journalArticle

4 Scopus citations

Abstract

Objective: To report our initial animal and human experience with a new multi-lumen catheter called MultiCross™ (Roxwood Medical, Inc.) in a porcine coronary model and patients with a chronic total occlusion (CTO). Methods: Preclinical safety study was done in the coronary vasculature of a porcine model. In a clinical setting, patients with a CTO of a coronary artery (n = 5) were enrolled. After an initial unsuccessful attempt using a conventional guidewire, operators could use the MultiCross system. The primary efficacy endpoint was successful recanalization (technical success) and the primary safety endpoint was serious adverse events through 30 days post-procedure. Results: The MultiCross catheter was used for all patients after failure of the initial attempt with a guidewire. Successful recanalization was achieved in all CTOs attempted (100%). No patients reported any adverse events at 30 days post-procedure. Conclusion: In this first-in-man experience, the MultiCross catheter has the potential to enhance crossing of CTOs.

Original languageEnglish (US)
Pages (from-to)E70-E75
JournalCatheterization and Cardiovascular Interventions
Volume85
Issue number3
DOIs
StatePublished - Feb 1 2015

Keywords

  • Coronary artery disease
  • Interventional devices/innovation
  • Percutaneous coronary intervention

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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