Subgroup Analysis From PERFORMANCE II Presented for Neuroguard IEP Carotid Stent System

October 16, 2026—At VIVA 2026, the Vascular InterVentional Advances conference, William A. Gray, MD, presented findings from a subgroup analysis of the PERFORMANCE II pivotal trial for the Neuroguard integrated embolic protection (IEP) 3-in-1 carotid stent system (Contego Medical LLC, distributed in the United States by Medtronic), which uses dual filtration and a purpose-built carotid stent&; In March 2026, Dr. Gray presented the 3-year outcomes from the trial at ISET.

As summarized in the VIVA press release, the PERFORMANCE II trial enrolled 305 patients at high risk for carotid endarterectomy, both symptomatic and asymptomatic, to assess the safety and efficacy of the Neuroguard IEP system for carotid artery stenting. At 30 days, there were four strokes (all minor), with one additional minor stroke at 1 year, and very low rates of target lesion revascularization.

The analysis evaluated the outcomes in PERFORMANCE II subgroups of patients who were symptomatic, patients who were aged > 75 years, and patients with significantly calcified lesions. Separately, any contralateral stroke events were assessed. The findings suggest that the Neuroguard IEP with double filtration appears to be performing as designed to reduce stroke risk for patients across all at-risk subgroups, reported VIVA.

The VIVA summary advised that the statistical power of the analysis was limited because of the low event rate in the pivotal trial. However, there were no differences in outcomes between symptomatic and asymptomatic patients, or between patients aged > 75 years or < 75 years.

VIVA reported that the analysis showed the following:

• When outcomes by site-reported calcification grade were analyzed, there was a trend toward worse outcomes in higher grades of lesion calcium.
• When core lab–controlled assessments of calcium grade were used instead (where two of three patients had moderate or severe lesion calcium), there were no differences in outcomes by calcium grade.
• There were no contralateral strokes reported in PERFORMANCE II, whereas a historical analysis from 2007 suggested an incidence of approximately 1%. The investigators noted that historical comparators with subset assessments are problematic because of incomplete data, lack of core lab adjudication, variable calcium scoring.

Post-hoc calcification analysis demonstrated a gap between site-reported and core laboratory–adjudicated calcification, with potential effects on outcome assessment, stated the VIVA summary.