CARENET

Objective

The objective of the CARENET Trial is to evaluate the periprocedural safety and efficacy of CGuardTM system in the treatment of carotid lesions in consecutive patients suitable for carotid artery stenting (CAS).

Study design

Prospective, multi-center, international, open label, single arm, non-randomized clinical trial. 30 consecutive patients will be enrolled in a total of up to 8 experienced centers including Germany, Poland and Belgium. Patient population will include neurologically symptomatic and asymptomatic patients who require carotid artery revascularization and are suitable for carotid artery stenting; symptomatic patients (with history of a transient ischemic attack, stroke or amaurosis fugax within the last 6 months on the ipsilateral side of the stenosis) with carotid stenosis ≥50% as diagnosed by angiography using NASCET methodology; and asymptomatic patients with carotid stenosis ≥80% as diagnosed by angiography using NASCET methodology. Enrollment has begun. The primary endpoint is 30 day MACE (death, stroke, MI).

Results

Device success was 100% and the pre RVD (Reference Vessel Diameter) was 79.9% and post procedure was 16.9% angiographic. 30 day MACE was 0%, and the incidence of patients with new ischemic lesions at 48 hours was 46.1%. The acute and 30 day results imply that the use of the CGuard™ system in patients undergoing carotid artery stenting is feasible and safe and suggest that the MicroNet™ covered stent offers clinical benefits for patients undergoing CAS.