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Hybernia Medical Post-Mechanical Thrombectomy Cerebral Cooling in Stroke

NCT06634303 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-03-17

No results posted yet for this study

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

DEVICE

Brain cooling

Brain cooling intervention in acute ischemic stroke patients post mechanical thrombectomy

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    collaborator OTHER

  • Hybernia Medical

    lead INDUSTRY

Principal Investigators

  • Marc Ribo, MD, PhD · Vall d'Hebron University Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-10-01
Completion
2026-02-20
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06634303 on ClinicalTrials.gov