Short-duration Selective Brain Cooling for Patients Undergoing Mechanical Thrombectomy

• Status: Suspended
• Trial end date: 2020-12-16
• Target enrollment: 0
• Participant gender: All

Summary

To determine the efficacy and safety of short-duration intra-artery selective brain cooling in addition to mechanical thrombectomy in patients with acute ischemic stroke.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Capital Medical University

Criteria

Inclusion Criteria:

• Acute ischemic stroke within 6 hours from symptom onset/last seen well.

• Occlusion (TIMI 0-1) of the basilar artery or distal intracranial carotid artery or middle (M1/M2) or anterior (A1/A2) cerebral artery as evidenced by CTA/MRA/DSA.

• Age ≥18 and ≤80

• No significant pre-stroke functional disability (mRS ≤ 1)

• The possibility to start treatment within 6 hours from onset.

• Informed consent given

Exclusion Criteria:

• Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0

• Baseline platelet count < 50.000/µL

• Baseline blood glucose of < 50mg/dL or >400mg/dl

• Severe, sustained hypertension (SBP > 220 mm Hg or DBP > 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained below these levels using commonly used medications in China for these purposes (including iv antihypertensive drips), the patient can be enrolled.

• Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.

• History of life threatening allergy (more than rash) to contrast medium

• Subjects who has received iv t-PA treatment beyond 4.5 hours from the beginning of the symptoms.

• Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery

• Renal insufficiency with creatinine ≥ 3 mg/dl

• Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.

• Subject participating in a study involving an investigational drug or device that would impact this study.

• Cerebral vasculitis

• Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤ 1, which includes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)

• Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).

• CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed).