NCT06634303

Hybernia Medical Post-Mechanical Thrombectomy Cerebral Cooling in Stroke

Hybernia Delta H (ΔH) Brain Cooling System for: Post-Mechanical Endovascular Cerebral Cooling

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Hybernia Medical · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

Reducing the temperature of tissue or organs (hypothermia) produces a protective state, through multiple molecular mechanisms, against adverse effects that arise from disrupted organ blood flow, e.g. in acute ischemic stroke (AIS). AIS is often caused by a blood clot that occludes a brain artery which, in turn disrupts brain blood flow. In large vessel occlusions, the current standard includes mechanical thrombectomy (MT), a minimally-invasive procedure that aims at removing the clot via endovascular means. In this case, brain cooling can lead to protection (neuroprotection) not only from the adverse effects of stroke/ischemia itself, but also from complications arising from sudden re-opening of the blocked artery through primary treatment, MT. This potential complication of MT is called reperfusion injury. In this first-in-human investigational deivce study, Hybernia Medical's endovascular brain cooling system will be applied in acute ischemic stroke patients undergoing MT. Post-MT, selective brain hypothermia will be induced and maintained over 30 minutes. Endpoints of this study include, clinical safety, device performance/usability, and clinical outcome.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	Brain cooling	Brain cooling intervention in acute ischemic stroke patients post mechanical thrombectomy

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-10-01
• Completion: 2026-02-20
• First posted: 2024-10-09
• Last updated: 2026-03-17

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study