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First-in-man Clinical Application of the Trackcath System in Endovascular Repair of Aortic Aneurysms – A Prospective Multi-centre Clinical Trial

      Introduction: Advantages of EVAR over traditional open repair includes reduced time under general anaesthesia, elimination of the pain and trauma associated with major abdominal surgery, reduced length of stay in the hospital and intensive care unit, and reduced blood loss. Fenestrated and branched stent grafts have enabled endovascular treatment for a large proportion of patients, which were normally unsuitable for endovascular repair. The cannulation of aortic side branches can be a challenging task. Normally, the branch identification can only be performed by using x-ray and contrast dye, with documented safety risks to the patient.
      The TrackCath system aims to support the identification and cannulation of aortic side branches with a guiding catheter or a guidewire. It uses the low-energy hot-wire anemometry principle to detect changes in blood flow velocity and direction. This measurement technology may help the localisation of the position of the side branches. It therefore provides an alternative technique for identifying side branches and target orifices without using x-ray and contrast dye.
      The primary objective of this study was to assess the safety and performance of the TrackCath system and to establish clinical evidence in patients with thoraco-abdominal and abdominal aortic aneurysm requiring endovascular intervention.
      Methods: The target subject population were male or female participants over 18 years of age who have been diagnosed with an aortic aneurysm requiring endovascular intervention. Enrolled patients required at least one cannulation during EVAR (e.g. fenestration of endograft, aortic side-branch or contralateral leg of endograft).
      The study was conducted in four study sites with broad experience of complex EVAR procedures. A sample size calculation showed that at least 24 patients with 42 target orifices are necessary to prove the expected procedural success rate, defined as successful TrackCath system delivery of the distal end of the guidewire or catheter to the selected targeted orifice.
      The safety was examined by reporting all device-related adverse events in the full analysis set, including additionally at least two roll-in patients at each study site. Secondary aimed to obtain additional scientific data about the use of the TrackCath system regarding e.g. procedure duration, contrast dye consumption, x-ray exposure, the patient's physical parameters and blood values and surgeons' satisfaction rate.
      Results: Between March 2018 and February 2019, a total of 40 patients were enrolled in the study.
      Preliminary statistical analysis of the study has evidenced successful achievement of primary endpoints for safety (100%) and performance (98%).
      During the study, no device-related serious adverse event occurred.
      In the statistical study population, 50 orifices were assessed concerning the successful TrackCath performance to deliver of the distal end of the guidewire or of the 4 French catheter to the selected targeted orifice.
      Analysis of clinical data recorded during the study evidenced as well the performance of the technology to identify side branches localisation using the blood flow velocity changes.
      Conclusion: The use of the TrackCath system is a safe procedure and does not increase the intra- or postoperative risks of EVAR
      Disclosure: Nothing to disclose

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