PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device.

ABSTRACT:

Objectives

The PERFORMANCE I study was designed to evaluate the safety and feasibility of the Neuroguard IEP® System, a novel carotid stent system with an integrated embolic filter and post-dilatation balloon, to treat clinically significant carotid artery stenosis.

Background

The risk of major adverse events during carotid artery stenting is comparable to carotid endarterectomy, however, the risk of minor stroke remains higher with stenting.

Methods

In total, 67 patients undergoing carotid artery stenting were enrolled at nine centers in Europe. Follow-up assessments included neurological exams, duplex ultrasound, 12-lead electrocardiogram, and cardiac enzyme analysis. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarctions ver

SUBMITTER: Langhoff R 

PROVIDER: S-EPMC10092178 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature