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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• Age 18 to 89

• Informed signed consent obtained from patient or legally authorized representative

• Clinical symptoms consistent with acute ischemic stroke

• Pre-stroke modified Rankin Scale (mRS) score 0-1

• National Institute of Health Stroke Scale (NIHSS) ≥ 6

• Alberta Stroke Program Early CT Score (ASPECTS) score 5-10

• IV tissue plasminogen activator (tPA) or Tenecteplase (TNK) may be administered within 4.5h of last known well (LKW), if patient eligible

• Mechanical thrombectomy (MT) treatment performed with arterial puncture within 24h of LKW.

• Pre-MT catheter angiogram shows target occlusion in intracranial ICA, M1 MCA, or M2 MCA

⁃ End of MT catheter angiogram shows achievement of moderate-to-complete reperfusion (modified Treatment in Cerebral Ischemia score or mTICI 2a-3)

Locations
Other Locations
Spain
Vall d'Hebron University Hospital
RECRUITING
Barcelona
Contact Information
Primary
Marc Ribo, MD, PhD
marcriboj@hotmail.com
+34 934 89 30 00
Backup
Miriam Correa Losada
miriam.correa@vhir.org
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2025-11
Participants
Target number of participants: 10
Treatments
Experimental: Post-Mechanical Cerebral Cooling
Acute ischemic stroke patients undergoing mechanical thrombectomy.
Related Therapeutic Areas
Sponsors
Leads: Hybernia Medical
Collaborators: Hospital Universitari Vall d'Hebron Research Institute

This content was sourced from clinicaltrials.gov