InspireMD, in partnership with NAMSA, is set to initiate the pivotal, single-arm CGUARDIANS II study to assess the CGuard Prime 80cm carotid stent system’s usage in transcarotid artery revascularisation (TCAR) procedures.

The study follows a strategic outsourcing collaboration announced by the companies in September 2022.

The multi-centre, prospective trial will focus on subjects at high risk for complications from carotid endarterectomy. It aims to use the device, which is designed to prevent stroke related to carotid stenosis, in combination with a Food and Drug Administration (FDA)-cleared TCAR neuro-protection system.

It aims to enrol at least 50 evaluable subjects to evaluate the acute device and technical success.

The trial allows for a maximum of 20% of subjects to be enrolled at any single site.

In addition to the main cohort, there is provision for an ancillary roll-in group of up to two subjects for each primary physician operator at the study sites, capping at 24 roll-in subjects in total.

InspireMD CEO Marvin Slosman said: “With more than 30,000 TCAR procedures performed in the US each year, TCAR is a rapidly growing procedure that represents a significant potential expansion of our addressable market and the lynchpin of our effort to serve the broadest patient population by supporting both CAS [carotid artery stenting] and TCAR carotid stenting procedures.

“We are very pleased to be working with NAMSA and leveraging their vascular clinical and regulatory expertise to execute this important study as efficiently as possible.”    

According to InspireMD, the first subject was enrolled in December 2024.

As a medtech contract research organisation, NAMSA provides comprehensive development services. It expanded its capabilities last month by acquiring the US-based medical device testing operations of WuXi AppTec. This move is expected to enhance NAMSA's clinical research testing services within the medtech sector.