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Clinical Trial
. 2022 Feb:35:85-90.
doi: 10.1016/j.carrev.2021.03.013. Epub 2021 Mar 20.

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

David Kandzari  1 , Steven Hearne  2 , Gautam Kumar  3 , Rajesh Sachdeva  3 , George Adams  4 , Benjamin Blossom  5 , Thom Dahle  6 , Kintur Sanghvi  7 , Mauricio G Cohen  8 , Gregory Imperi  9 , Robert Riley  10 , Alexandra Popma Almonacid  11
Affiliations
Clinical Trial

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

David Kandzari et al. Cardiovasc Revasc Med. 2022 Feb.

Abstract

Background: The 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.

Methods: Patients 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.

Results: Among 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%).

Conclusions: Among 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.

Trial registration: ClinicalTrials.gov NCT03763747.

Keywords: Angioplasty; Dilation; Percutaneous coronary intervention; Scoring balloon.

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Conflict of interest statement

Declaration of competing interest The following authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Kandzari reports institutional research/grant support from Abbott Vascular, Biotronik, Boston Scientific, Cardiovascular Systems, Inc., OrbusNeich, Medtronic and Ablative Solutions; and personal consulting honoraria from Cardiovascular Systems, Inc., Magenta Medical and Medtronic. Dr. Sanghvi reports institutional research/graft support from Boston Scientific, Cardiovascular system Inc., Recor Medical, Ablative solutions and personal consulting honoraria and royalty payments from Cordis Cardinal Health. Dr. Cohen reports personal consulting honoraria from Medtronic, Merit Medical, Terumo Medical, Astra Zeneca, Zoll, and Abiomed and ownership in Accumed Radial Systems. Dr. Almonacid reports institutional grants from Boston Scientific, Medtronic, Abbott Vascular, COOK, and Terumo. Drs. Hearne, Kumar, Sachdeva, Adams, Blossom, Dahle, Imperi and Riley declare no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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