First-in-Human Evaluation of the Safety and Efficacy of a Novel Stent Positioning Assistance System for Precise Positioning of Coronary Stents.

ABSTRACT:

Objectives

This study was planned for evaluating the safety and efficacy of SPAS (stent positioning assistance system) device in first-in-human procedures.

Background

SPAS is a novel device that can be used for improved positioning of coronary stents.

Methods

Consecutive patients underwent percutaneous coronary intervention (PCI) with the SPAS device. Device-related adverse and serious adverse events were evaluated in addition to a dedicated questionnaire completed by operators immediately after using SPAS.

Results

The SPAS device was deployed in 55 PCI procedures, comprising of heavily calcified lesions (33.3%), totally occluded (7.4%), and severely tortuous vessels (7.4%). In these procedures, nonbifurcation and nonostial (53.7%), bifurcation (22.2%), and edg

SUBMITTER: Hellou E 

PROVIDER: S-EPMC8977329 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature