First-in-man evaluation of the MOMO cobalt-chromium carbon-coated stent.

AIMS: Bare metal stents continue to be used for the interventional treatment of coronary artery disease. We report the clinical and angiographic results of a multicentre, single-arm evaluation of safety and feasibility of the MOMO stent (Japan Stent Technology Co., Ltd, Okayama Research Park Incubation Centre, Okayama, Japan).

METHODS AND

RESULTS

The MOMO stent is a novel thin-strut cobalt-chromium carbon-coated stent for the treatment of de novo coronary artery disease (CAD). In this prospective, non-randomised, single-arm study, 40 patients (stable and unstable angina) with single-vessel CAD were recruited into the study from three centres. Patients with lesions ≤15 mm in length and with a target vessel diameter of ≥3 mm were eligible. Angiographic follow-up was performed at six months. Quantitative coronary angiography (QCA) was used to measure acute gain and late luminal loss (LLL). Intravascular ultrasound (IVUS) was performed in 15 consecutive patients from two centres to assess the degree of neointimal proliferation within the stented segment at six-month follow-up. The MOMO stent performed well without any procedural complications with an acute procedure and technical success rate of 100%. Repeat revascularisation was performed in six patients (15%) during the six-month follow-up. Ischaemia-driven revascularisation was documented in three patients (7.5%). No myocardial infarction, stent thrombosis or cardiac death was observed. One non-cardiac death was reported secondary to lung cancer. Binary restenosis was 12.5% (n=5), and the LLL was 0.54±0.3 mm.

CONCLUSIONS

This first-in-man experience demonstrates proof of concept of the safety and feasibility of the MOMO cobalt-chromium carbon-coated stent for patients with single focal de novo lesions presenting with stable and unstable CAD.