Safety and Effectiveness of a Novel Microcatheter in Coronary Chronic Total Occlusions-The BIOMICS Study.

BACKGROUND

Chronic total occlusion (CTO) remains the most complex anatomical subset of lesions in percutaneous coronary intervention (PCI), often requiring advanced techniques and technologies, including the use of microcatheters.

METHODS

The BIOMICS study is a premarket first-in-human prospective, multicenter, open-label, single-arm trial investigating the safety and efficacy of a novel coronary microcatheter (BioMC, Biosensors International) in 100 patients with symptoms of ischemia undergoing elective CTO-PCI. The primary efficacy end point of the study was device success defined according to the CTO-ARC (Chronic Total Occlusion Academic Research Consortium) criteria namely the ability of the microcatheter to successfully facilitate placement of a guide wire beyond the occluded coronary segment. The primary safety end point was the incidence of in-hospital cardiac death or myocardial infarction at hospital discharge.

RESULTS

Hundred patients were recruited between March 2022 and January 2023. The primary efficacy end point was achieved in 75% of patients (95% CI, 65.3%-83.1%; < .0001 for superiority compared to the prespecified performance goal of 54%). The primary safety end point of in-hospital cardiac death or myocardial infarction was observed in 2% of the patients. There were no study device-related coronary perforations or device failures.

CONCLUSIONS

The use of a novel coronary microcatheter during CTO-PCI was associated with a high device success and an excellent safety profile.