Related Experiment Video
Updated: Dec 7, 2025
Author Spotlight: A Novel Approach to Cerebral Ischemia Modeling – Enhancing Reperfusion and Simplifying Procedure
Published on: May 31, 2024
Common carotid artery endovascular clamping for neuroprotection during carotid stenting: Flow-gate system as an
Roberto Gabrielli1, Tommaso Castrucci1, Andrea Siani1
1Unit of Vascular, Endovascular and Emergency Vascular Surgery, "S. Eugenio" Hospital, Rome, Italy.
Insights
This study shows the FlowGate2 system effectively protects the brain during carotid artery stenting (CAS). The novel endovascular clamping technique resulted in a low rate of micro-embolic infarction and no major strokes.
Area of Science:
- Vascular Surgery
- Interventional Neurology
- Medical Device Technology
Background:
- Carotid artery stenosis (CAS) poses a significant risk of stroke.
- Cerebral protection during CAS procedures is crucial to minimize embolic events.
- Existing neuroprotection methods have limitations.
Purpose of the Study:
- To evaluate the clinical experience and efficacy of the FlowGate2 system for neuroprotection during CAS.
- To assess the safety and effectiveness of a novel endovascular clamping technique for CAS management.
Main Methods:
- Forty-five patients with asymptomatic internal carotid artery stenosis (≥70%) underwent stenting.
- A unique endovascular clamping technique using the FlowGate2 system was employed for cerebral protection.
- This involved common carotid artery occlusion, flow inversion, and a 30-second debris washout period post-stenting.
- Diffusion-weighted imaging magnetic resonance (DWI) was used to assess micro-embolic scattering of infarction.
Main Results:
- Transient clamping intolerance occurred in 4% of patients.
- One patient (2%) experienced a minor stroke with DWI-detected micro-embolic lesions.
- No major strokes or deaths were observed at 3-month follow-up.
- NIHSS scores remained stable across all patients at 1, 3, and 6 months.
Conclusions:
- The FlowGate2 system demonstrates efficacy in providing neuroprotection during CAS.
- This innovative endovascular clamping approach appears safe and effective for managing CAS.
- Further validation through a large controlled trial is warranted.
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.
