Conclusions drawn from a recent study have pointed to the potential of a novel carotid stent system that could benefit patients at high risk of complications from carotid endarterectomy (CEA). The trial revealed that the Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Contego Medical) performed exceptionally well, with a primary endpoint occurrence of 2.8%. The trial’s research team found that at 30 days, the rate of all stroke was 1.3%, with no major strokes reported. Further findings also revealed that the stroke/death rate was 1.6%, and the combined stroke/death/MI rate was 2.3%. “The rate of major adverse events was extremely low, demonstrating the study system is a safe, effective, and durable treatment option for high-risk patients,” said the paper’s authors, led by William A. Gray, MD, from the Lankenau Heart Institute in Wynnewood, Pennsylvania. Primary endpoint The PERFORMANCE II trial (Protection against Emboli during caRotid artery stenting using a 3-in-1 delivery system comprised oF a pOst-dilation balloon, integRated eMbolic filter, and A Novel Carotid stEnt II) also noted that the 12-month primary endpoint occurred in 2.8%. This endpoint occurred in the absence of major strokes, clinically driven target lesion revascularizations, stent thromboses or neurological deaths. The 30-day all stroke plus ipsilateral stroke through 12 months rate was 1.8%. “The novel stent system has shown significant potential in reducing procedural risks and improving outcomes for patients who may not be ideal candidates for surgery,” the paper’s authors added. In an accompanying editorial, Bernardo Cortese MD, Marco Frazzetto MD and Mehdi H. Shishehbor PhD, all from the Harrington Heart and Vascular Institute, University Hospitals in Cleveland, Ohio, recognized that carotid artery stenting (CAS) and carotid endarterectomy (CEA) were effective treatments, although CAS has been linked with a higher risk of periprocedural stroke. Protection filter The commentators noted that the Neuroguard IEP system addressed this concern by integrating an embolic protection filter that captured microemboli, which were often missed by conventional filters. “To our knowledge, the 30-day rate of all stroke plus ipsilateral stroke through 12 months of 1.8% is the lowest ever reported in a similar multicenter trial,” they said. Although the experts credit the trial’s design and outcomes, they stressed the need for further research arguing that head-to-head trials against conventional carotid stents and CEA were necessary. “This study does not completely clarify the performance and potential of this device, and we are eagerly awaiting new studies addressing these limitations.” Study Methodology The PERFORMANCE II trial enrolled a total of 305 patients at 32 centers in the United States and Europe. The mean age was 69.6±7.5 years, of which 65.9% were male, and 20% were symptomatic. The primary endpoint was the composite of major adverse events defined as death, all stroke and MI within 30 days of the procedure, plus ipsilateral stroke through 12 months. Sources: Gray WA, Metzger DC, Zidar J, et al. The PERFORMANCE II Trial: A Prospective Multicenter Investigation of a Novel Carotid Stent System. JACC Cardiovasc. Interv. 2025;18:367–376. Cortese B, Frazzetto M, Shishehbor MH. All-in-One Integrated Device for Carotid Stenting: The Last Mile to Attain Surgical Revascularization? JACC Cardiovasc. Interv. 2025;18:377–379. Image Credit: Игорь Гончаров – stock.adobe.com