Stroke, Acute Cerebral Infarction
Conditions
Brief summary
This study aims to evaluate the hypothesis that thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days as compared to medical management alone in appropriately selected subjects with the Target Mismatch Profile and an MCA (M1 and M2 segment) or ICA occlusion or BA who have endovascular thrombectomy initiated between 6-24 hours after last seen well.
Detailed description
Study design is a prospective, single-center study of acute ischemic stroke patients with large artery occlusion in 6-24 hours of stroke onset. According to patients or their family members' willing, patients who meet the inclusion criteria will be assigned to endovascular thrombectomy group with approved devices (only the devices listed in this protocol are approved for us) plus standard medical therapy or control group (standard medical therapy alone) after undergoing either CT Perfusion or MR Perfusion studies. Patients who have evidence of an ICA or MCA M1 or M2 or BA occlusion and a Target Mismatch Profile will be enrolled. The intent of this study is to support thrombectomy beyond the currently labeled 8 hour indicated time limit in wake up, unclear onset, and late presenting ischemic stroke subjects, who currently have no other option besides medical management of their symptoms, with careful selection. The study will enroll up to 55 patients. The primary endpoint, the modified Rankin Score, will be assessed at 3 months.
Interventions
PROCEDUREEndovascular Thrombectomy
Procedure: Endovascular Thrombectomy Device: Trepo trevor Retriever Device: Solitaire™ FR Revascularization Device
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria: 1. Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke 2. Age ≥18 years 3. NIHSS ≥ 6 4. Endovascular thrombectomy can be initiated (femoral puncture) between 6 and 24 hours after time last know well 5. No significant pre-stroke disability (pre-stroke mRS must be ≤ 3 ) 6. Patient/Legally Authorized Representative has signed the Informed Consent form Imaging Inclusion Criteria: 1. ICA or MCA-M1 or MCA-M2 or BA occlusion (carotid occlusions can be cervical or intracranial with or without tandem MCA lesions) as evidenced by MRA or 4D-CTA 2. Target Mismatch Profile on CT perfusion or MR perfusion: ischemic core volume is ≤ 70 ml, mismatch ratio is \>/= 1.2 )
Exclusion criteria
Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Good Functional Independence | 90 days | This outcome will look at the proportion of patients with mRS 0-2 at day 90. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | 90 days | Death |
| Symptomatic Intracranial Hemorrhage | 24 hours | Defined as NIHSS worsening of 4 or more points associated with ICH within 24 hours of randomization |
Countries
China
Contacts
Primary ContactMIN LOU, Ph.D.
Outcome results
None listed