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

Sidik, N.; McEntegart, M.; Joshi, F.; Owens, C.; Shaukat, A.; Gallagher, S.; Strange, J.; Tang, K.; Elghamaz, A.; Mozid, A.; Ladwiniec, A.; Oldroyd, K.; Schuette, D.; Copt, S.; Spratt, JC.

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

All Authors

Sidik, N.

McEntegart, M.

Joshi, F.

Owens, C.

Shaukat, A.

Gallagher, S.

Strange, J.

Tang, K.

Elghamaz, A.

Mozid, A.

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LTHT Author

Mozid, Abdul

LTHT Department

Cardiology
Cardio-Respiratory

Publication Date

2024

Item Type

Journal Article

Abstract

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%; P < .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.