First clinical experiences with an endovascular clamping system for neuroprotection during carotid stenting

Objectives. This report evaluates the feasibility and efficacy of an endovascular blood flow blockage technique to prevent intracerebral embolization of plaque debris during carotid artery stenting. Methods. Forty-two patients were enrolled in five clinical sites in Germany and Italy with either an asymptomatic internal carotid artery stenosis greater than or equal to75% (mean 87%) or a symptomatic stenosis >60% (mean 85%). Cerebral protection during the stenting procedure was achieved using an endovascular clamping technique, obtained by occlusion of the external and common carotid artery via two independently inflatable balloons integrated in the Mo.Ma((R)) system. Blood with particulate plaque debris was aspirated before flow was restored. The patient's clinical and the neurological status were assessed during intervention, at discharge, and at 3 months follow-up. Results. Stenting was performed in all but one patient. The mean flow occlusion time was 10.6 +/- 6.5 min. Transient clamping intolerance was observed in five patients (12%). In two patients, neurological deficits persisted for 2 and 12 h, respectively. Two minor strokes (4,7%) occurred at 5 and 72 h after the procedure. No major strokes or deaths were observed at 3 months follow-up. Conclusions. This first clinical experience with the Mo.Ma((R)) device substantiates the feasibility of endovascular clamping in preventing cerebral embolization during carotid artery stenting.