Ischemic Stroke
Conditions
Keywords
Therapeutic Hypothermia, Cooling, Stroke, Neurological Acute Care
Brief summary
The primary objective of this study is to determine the feasibility and safety of achieving rapid hypothermia with the Proteus Intravascular Temperature Management (IVTM) system for patients experiencing acute ischemic stroke due to a large vessel occlusion.
Interventions
DEVICEThermogard XP3
Cooling with the ZOLL® Circulation catheter and the ZOLL® Intravascular Temperature Management system to initiate and maintain hypothermia for 6 hours as an adjunct to endovascular Recanalization.
PROCEDURERecanalization only
Standard of Care for recanalization
Sponsors
ZOLL Circulation, Inc., USA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
All Inclusion Criteria must be answered YES for Patient to be eligible. 1. Age ≥18 and ≤85; 2. Signs and symptoms consistent with an acute ischemic stroke with anterior circulation large vessel occlusion (M1 MCA, carotid-terminus occlusion, Tandem occlusion allowed (Extracranial ICA+carotid T or M1 MCA)) as determined by CT imaging; (i.e., hyperdense sign on non-contrast CT or CT angiogram); 3. Ability to perform arterial puncture within 24 hours from symptom onset or LKN; 4. ASPECTS score of 6-10 on non-contrast CT of the brain if under 80 years; ASPECTS 9-10 if age 80-85; 5. For transfer patients with anticipated arterial puncture greater than 6 hours from symptom onset or LKN, qualifying imaging must be performed within 2 hours prior to enrolling hospital arrival; or with a newly obtained non-contrast CT scan if this time is exceeded 6. Candidate for endovascular thrombectomy therapy in accordance with best practices per AHA standard stroke guidelines meeting all labeling requirements for EVT in the trial; 7. No contraindications to general anesthesia, conscious sedation or allergies to any components associated with the anticipated diagnostic or treatment procedures that cannot be treated; 8. A pre-stroke modified Rankin Score (mRS) of 0 or 1 (Appendix 4); 9. Baseline CT scan shows no hemorrhage; 10. NIHSS greater than or equal to 8 (Appendix 3); 11. Patient is capable of complying with study procedures and agrees to complete all required study procedures, study visits and associated activities; 12. Legally authorized representative must be able to understand and give written informed consent. Patient will assent if capable. Patient may be re-consented once it is established that there is no memory loss or cognitive impairment. 5.2
Exclusion criteria
In order to be eligible for participation, patients must meet all Inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Test Arm patients achieving target temperature | 1 hour after thrombectomy | Percentage of Test Arm patients achieving target temperature \< 34 ºC within 1 hour of arterial puncture for thrombectomy |
| Mean door-to-Recanalization time | perioperative | door-to-Recanalization time |
| Rate of hemorrhagic conversion in each arm within 36 hours of Recanalization | 36 hours | Rate of hemorrhagic conversion |
Countries
United States
Outcome results
None listed