Procedural Effectiveness With a Focused Force Scoring Angioplasty Catheter: Procedural and Clinical Outcomes From the Scoreflex NC Trial

Abstract

BackgroundThe Scoreflex NC scoring angioplasty catheter is designed with a short rapid-exchange tip distal to a non-compliant, high-pressure balloon and an integral wire outside of the balloon, such that the guidewire and the integral wire act as scoring elements during balloon inflation. The external scoring elements enable a focal stress pattern facilitating expansion of resistant lesions at lower pressures using a focused force angioplasty effect. MethodsPatients undergoing elective percutaneous coronary intervention (PCI) were enrolled in a prospective, single-arm study conducted at 12 centers in the United States. The primary endpoint was device procedural success, defined as the composite of successful device delivery to the target lesion with balloon inflation and deflation; absence of vessel perforation, flow-limiting dissection or reduction in TIMI flow from baseline; and achievement of final TIMI 3 flow. ResultsAmong 200 patients (234 lesions), lesion complexities included: bifurcation disease (37.6%), moderate/severe calcification (36.6%), and total occlusions (5.0%). Successful delivery to the target lesion, inflation and removal of the balloon catheter was achieved in 95.5% of patients (191/200). Procedural success was achieved in 93.5% (187/200) of patients, and final TIMI 3 flow was observed in 99.0% of cases (198/200). No unanticipated device-related events occurred. In-hospital major adverse events were reported in 4.5% of patients (9/200), related to periprocedural myocardial infarction (8/200, 4.0%) and target lesion revascularization (1/200, 0.5%). ConclusionsAmong patients undergoing elective PCI and with varied lesion complexity, these results support the safety and effectiveness of a dilation strategy using the Scoreflex NC scoring catheter.