Accurate Stent Placement in Challenging Percutaneous Coronary Interventions Using the Stent Positioning Assist System

To evaluate safety and accuracy of stent placement by Stent Positioning Assistance System (SPAS), an innovative device that allows for mm-precise manipulation and placement of stents in percutaneous coronary interventions (PCI).

In PCI, controlled stent manipulation and precise stent placement remain compromised despite developments in stents and imaging.

Sixty-seven patients with various lesion types that required precise stenting were included in this study. All patients were treated with the support of SPAS. Safety was evaluated by looking at procedural success, occurrence of intraprocedural complications and incidence of (device related) adverse events. In subsets of procedures, usability feedback was collected and stent positioning accuracy was assessed with intravascular imaging.

In 67 patients, 84 stents were implanted by 5 operators. Intravascular Ultrasound (IVUS, n = 6) and Optical Coherence Tomography (OCT, n = 15) was used to assess stent position after placement. Using SPAS, procedural success was achieved in all 67 (100%) cases. There were no intraprocedural complications nor any adverse events. In most procedures, SPAS provided significant support to the operator and the positive procedure impact was rated as major. OCT results showed accurate stent placement with a positioning error of <1 mm (n = 11), 1-2 mm (n = 2) and 3 mm (n = 1) relative to predefined targets; generally the ostium of a side branch or of the coronary artery, and a stent overlap of 1-3 mm in 5 stent-to-stent situations.

SPAS is safe and allows for enhanced control and accurate stent placement in different types of PCI procedures without impairing procedural workflow.