Common carotid artery endovascular clamping for neuroprotection during carotid stenting: Flow-gate system as an innovative treatment approach

Objectives: We here report our clinical experience in CAS management through common carotid artery endovascular clamping with FlowGate2 system.

Methods: Forty-five patients were enrolled with de novo asymptomatic internal carotid artery stenosis ≥70%. Cerebral protection during the stenting procedure was achieved using a unique endovascular clamping technique developed in our Institution which includes: (a) the occlusion of the common carotid artery only, through inflatable balloons integrated in the FlowGate2 Balloon Guide Catheter system; (b) flow inversion connecting catheter to 16 G blood cannula previously placed in arm vein; (c) after the placement of the stent, the flow inversion is maintained for 30 s to allow debris washout. The related primary end-point was the rate of Diffusion-weighted imaging magnetic resonance (DWI) micro-embolic scattering of infarction. The patient's clinical and the neurological status were assessed prior, during and after intervention, at discharge.

Results: Transient clamping intolerance was observed in two patients (2/45; 4%). One minor stroke (1/45; 2%) occurred 8 hr the procedure with DWI ipsilateral micro-embolic lesions. No major strokes or deaths were observed at 3 months follow-up. DWI demonstrated ipsilateral micro-embolic scattering of infarction, in one asymptomatic patient. In all patients, no worst changes in NIHSS scale assessment were recorded at 1, 3, and 6 months.

Conclusions: Our data confirmed the efficacy of FlowGate2 in terms of neuroprotection during CAS. To our knowledge, these are the first published data on this innovative approach developed in our institution. A large controlled trial is ongoing to confirm preliminary evidences.