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Early clinical results show safety of mesh-covered embolic prevention stent system
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Use of a mesh-covered embolic prevention stent system in patients undergoing carotid artery stenting was associated with successful implantation and prevention of postprocedural embolic events, including no occurrence of stroke during 6 months of follow-up, according to results published in the Journal of Endovascular Therapy.
The prospective, single-center study included 30 consecutive patients with symptomatic (83%) or high-grade internal carotid artery stenosis. The mean age was 73 years and 21 were men.
Patients were treated with a double-layer carotid stent system (CGuard Embolic Prevention System, InspireMD), which features an inner open-cell nitinol design and an outer closed-cell polyethylene terephthalate layer. The stent system was designed to prevent periprocedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery and branch vessels, according to a company press release.
In this study, the average stenosis of the treated arteries was 84%. Mean lesion length was 16.6 mm.
The rate of implant success was 100%. There were no periprocedural or postprocedural complications.
At 6 months, the researchers reported no deaths, major adverse events, minor/major strokes or new neurological symptoms. Modified Rankin scale score improved from 1.56 at baseline to 0 after the procedure in patients with symptomatic internal carotid artery stenosis, according to findings.
All vessels treated with the stent system remained patent at 6-month follow-up. When the researchers performed diffusion-weighted MRI in 19 of 30 patients, they found no new ipsilateral lesions after 30 days or after 6 months compared with baseline, according to the release.
In addition, the stent system provided high radial force and strong support in stenotic lesions, according to the researchers. Its structure, when compared to other stents, adapted well to changes in vessel diameter and direction, according to the release. Further, the MicroNet mesh of the stent system did not cause any changes to specific mechanical parameters of the underlying stent, according to the release.
“Because of its structure, the novel CGuard Embolic Prevention Stent System is characterized by a high flexibility combined with a high radial force and very good plaque coverage. These first clinical results demonstrate a very safe implantation behavior without any stroke up to 6 months after the procedure,” Christian Wissgott, MD, assistant director of Westkustenklinikum, Heide, Germany, and colleagues wrote in the study.
Disclosure: The researchers report no relevant financial disclosures.
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