The investigator-initiated trial in Germany used a 10 mm diameter CGuard stent with SmartFit technology across a broad range of carotid artery diameters. Variations in diameters of the common carotid artery (CCA) and the internal carotid artery (ICA), as well as inaccurate x-ray images caused by projection angles, make choosing the correct size choice of a carotid stent challenging, according to principal investigator Christian Wissgott.
Wissgott concluded through in-vitro bench testing that the CGuard demonstrated a near-flat chronic outward radial force in the range of 5.5 to 9.0 mm diameters, meaning the force against a vessel wall in a 5.5 mm vessel and that in a 9.0 mm vessel are similar. He then conducted the initial clinical study of 30 patients with carotid artery diameters ranging from 9.0 mm in the CCA to 5.2 mm in the ICA and diameter changes between the CCA and ICA of 2.6 mm.
Wissgott demonstrated that the 10 mm diameter CGuard readily adapts to a range of carotid artery diameter changes and offers additional protection against embolic events that can lead to stroke, according to a company statement. Patients exhibited no immediate complications and no strokes at the six-month follow-up. No new ipsilateral lesions were observed in a subgroup of 10 patients who underwent DW-MRI follow-up at 30 days and at six months following the procedure, InspireMD said.
Wisgott is a professor at the Institute for Diagnostic and Interventional Radiology/Neuroradiology at Westkuestenklinikum Heide – Academic Teaching Hospital of the Universities of Kiel, Luebeck and Hamburg. He presented the study’s results last week at the Leipzig Interventional Course in Leipzig, Germany.
“One of the keys to successfully treating patients with carotid artery disease is to employ a device that is optimally sized,” Wissgott said in the statement. “I believe CGuard EPS with SmartFit technology overcomes this significant challenge.”