The CathPilot: Performance Validation and Preclinical Safety and Feasibility Assessment

James J. Zhou, Yara Alawneh, Alykhan Sewani, Mohammadmahdi Keshavarz, Mohammadmahdi Tahmasebi, Trisha Roy, Ahmed Kayssi, Andrew Dueck, Graham A. Wright, M. Ali Tavallaei

Research output: Contribution to journalArticlepeer-review


<bold><italic>Objectives</italic></bold>: Peripheral endovascular revascularization procedures often fail due to technical limitations of guidewire support, steering, and visualization. The novel CathPilot catheter aims to address these challenges. This study assesses the safety and feasibility of the CathPilot and compares its performance to conventional catheters for peripheral vascular interventions. <bold><italic>Methods</italic></bold>: The study compared the CathPilot to non-steerable and steerable catheters. The success rates and access times for a relevant target inside a tortuous vessel phantom model were assessed. The reachable workspace within the vessel and the guidewire&#x0027;s force delivery capabilities were also evaluated. To validate the technology, chronic total occlusion tissue samples were used <italic>ex vivo</italic> to compare crossing success rates with conventional catheters. Finally, <italic>in vivo</italic> experiments in a porcine aorta were conducted to evaluate safety and feasibility. <bold><italic>Results</italic></bold>: The success rates for reaching the set targets were 31&#x0025;, 69&#x0025;, and 100&#x0025; with the non-steerable catheter, the steerable catheter, and the CathPilot, respectively. CathPilot had a significantly larger reachable workspace, and allowed for up to four times higher force delivery and pushability. In crossing of chronic total occlusion samples, the CathPilot achieved a success rate of 83&#x0025; and 100&#x0025;, for fresh and fixed lesions respectively, which was also significantly higher than conventional catheters. The device was fully functional in the <italic>in vivo</italic> study, and there were no signs of coagulation or damage to the vessel wall. <bold><italic>Conclusion</italic></bold>: This study shows the safety and feasibility of the CathPilot system and its potential to reduce failure and complication rates in peripheral vascular interventions. The novel catheter outperformed conventional catheters in all defined metrics. This technology can potentially improve the success rate and outcome of peripheral endovascular revascularization procedures.

Original languageEnglish (US)
Pages (from-to)1-10
Number of pages10
JournalIEEE Transactions on Biomedical Engineering
StateAccepted/In press - 2023


  • angioplasty
  • Arteries
  • atherectomy
  • catheter limitations
  • catheter manipulation
  • catheter navigation
  • Catheters
  • CathPilot
  • chronic total occlusions
  • endovascular
  • guidewires
  • Lesions
  • Navigation
  • non-steerable catheter
  • peripheral artery disease
  • Peripheral vascular interventions
  • Phantoms
  • Safety
  • steerable catheter
  • Visualization

ASJC Scopus subject areas

  • Biomedical Engineering


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