Real-world safety and performance of the Navitian microcatheter in complex PCI: the rEpic04 observational study

Introduction and objectives: Coronary microcatheters play a key role in contemporary percutaneous coronary intervention (PCI), particularly in complex anatomies such as chronic total coronary occlusions. Under the European Medical Device Regulation (MDR 2017/745), post-market clinical follow-up (PMCF) studies are required to confirm safety and performance. However, PMCF evidence on coronary microcatheters remains limited. Our primary endpoint was to assess device effectiveness, defined as successful lesion or occlusion crossing. Procedural effectiveness was defined as final Thrombolysis in Myocardial Infarction grade-3 flow with < 30% residual percent diameter stenosis. Device safety endpoints included the absence of device-related mechanical failures, including rupture, kinking, or complicated retrieval. Methods: This prospective, multicenter, multinational, observational PMCF study evaluated the safety and performance of a coronary microcatheter (Navitian, iVascular, Spain) used according to CE-marked indications. Adult patients in whom the use of the device was attempted, usually in combination with other devices, were consecutively included. Clinical outcomes were assessed during in-hospital stay up to discharge. Results: A total of 102 patients with 115 coronary lesions were included. Lesion complexity was high: 57.4% chronic total coronary occlusions, 87.8% were American Heart Association type B2/C lesions, and 47.0% had significant calcification. Device effectiveness for lesion or occlusion crossing, evaluable in successfully wired lesions, was 95.2%. Procedural success was achieved in 100% of cases in which the device crossed. No device-related safety failures were observed. None of the adverse clinical events observed (4.3%) were adjudicated to the microcatheter. Conclusions: In this prospective, multinational PMCF study, the Navitian coronary microcatheter demonstrated high effectiveness and an excellent device-related safety profile in a real-world complex PCI, supporting its continued use in routine complex PCIs. (Clinicaltrials.gov NCT05292118). Keywords: Microcatheter. Complex PCI. Real-world data. Effectiveness. Safety.