Optimizing Stent Placement in Ostial Coronary Lesions With the Floating Balloon Technique: The OSTIAL (Optimizing Stent In Aorto‐Ostial Lesion) Pivotal Study

ABSTRACT Background Managing aorto‐ostial coronary lesions during percutaneous coronary interventions (PCI) presents significant challenges due to complex anatomy, catheter instability, and risks of stent misplacement. Aims The OSTIAL pivotal study aimed to assess the feasibility and precision of the floating balloon technique for optimizing stent placement in aorto‐ostial lesions (AOL), with post‐procedural coronary computed tomography angiography (CCTA) used to evaluate stent positioning. Methods This prospective, dual‐center observational study included 12 patients undergoing PCI for AOL using the floating balloon technique. The technique stabilizes the guiding catheter by positioning a balloon in the aorta, thereby defining the aorto‐ostial landing zone (AOLZ) for precise stent placement. Post‐procedural CCTA were systematically performed to assess the positioning of the stent. The primary outcome was technical success including optimal stent placement within the AOLZ and proximal anatomy‐dependent geographic miss. Results The primary outcome was achieved in 83% of cases, with 66% showing complete AOLZ coverage and 17% classified as a proximal anatomy‐dependent geographic miss. Proximal procedure‐dependent geographic miss occurred in only 17% of cases, with limited stent protrusion into the aorta (2.3 and 2.9 mm). Conclusions The floating balloon technique demonstrated feasibility and precision in optimizing stent placement in AOL, as assessed by CCTA. It offers a promising, cost‐effective, and practical alternative to other techniques. Larger studies are required to confirm its efficacy and long‐term benefits.