Complex Coronary Interventions with the Novel Mozec™ CTO Balloon: The MOZART Registry

BACKGROUND: Mozec™ CTO is a novel semicompliant rapid-exchange PTCA balloon catheter with specific features dedicated to treat complex coronary lesions like chronic total occlusions (CTOs). However, no data have been reported about the performance of this device in an all-comers population with complex coronary lesions. METHODS: We evaluated the safety and success rate of Mozec™ CTO balloon in 41 consecutive patients with chronic stable angina and complex coronary lesions (15 severe calcified coronary stenoses, 15 bifurcation lesions with planned two-stent intervention, and 11 CTOs). Safety was assessed reporting the balloon burst rate after inflation exceeding the rated burst pressure (RBP) according to the manufacturer’s reference table. Success was defined as the possibility to advance the device further the target lesion. RESULTS: The Mozec™ CTO balloon showed an excellent performance with a 93.3% success in crossing tight and severely calcified lesions (14/15 pts), a 93.3% success in engaging jailed side branches after stent deployment across bifurcations (14/15 pts), and a 90.9% success in crossing CTO lesions (10/11 pts). The burst rate at RBP of the Mozec™ CTO balloon was 6.7% (1/15 balloons) in the tight and severely calcified lesions, 6.7% (1/15 balloons) when dilating jailed vessels, and 9.1% (1/11 balloons) in CTOs. CONCLUSIONS: The novel Mozec™ CTO balloon dilatation catheter showed promising results when employed to treat complex lesions in an all-comers population. Further studies should clarify if this kind of balloon might reduce the need of more costly devices like over-the-wire balloons and microcatheters for complex lesions treatment.