Last updated: November 21, 2022
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Cerebral Ischemia
Thrombosis
Stroke
Treatment
N/AClinical Study ID
NCT03502408
yan2017-150
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Clinical Inclusion Criteria:
- Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke
- Age ≥18 years
- NIHSS ≥ 6
- Endovascular thrombectomy can be initiated (femoral puncture) between 6 and 24 hoursafter time last know well
- No significant pre-stroke disability (pre-stroke mRS must be ≤ 3 )
- Patient/Legally Authorized Representative has signed the Informed Consent form Imaging Inclusion Criteria:
- ICA or MCA-M1 or MCA-M2 or BA occlusion (carotid occlusions can be cervical orintracranial with or without tandem MCA lesions) as evidenced by MRA or 4D-CTA
- Target Mismatch Profile on CT perfusion or MR perfusion: ischemic core volume is ≤ 70ml, mismatch ratio is >/= 1.2 )
Exclusion
Exclusion Criteria: Clinical Exclusion Criteria:
- Other serious, advanced, or terminal illness (investigator judgment) or lifeexpectancy is less than 90 days
- Subject with a co-morbid disease or condition that would confound the neurological andfunctional evaluations or compromise survival or ability to complete follow-upassessments
- Unable to undergo a contrast brain perfusion scan with either MRI or CT
- Pregnant
- Known serious sensitivity to radiographic contrast agents
- Treated with rtPA >6 hours after time last known well
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency;recent oral anticoagulant therapy with INR > 3 (recent use of one of the new oralanticoagulants is not an exclusion if estimated GFR > 30 ml/min).
- Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
- Current participation in another investigational drug or device treatment study
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
- Any other condition that, in the opinion of the investigator, precludes anendovascular procedure or poses a significant hazard to the subject if an endovascularprocedure was performed. Neuroimaging Exclusion Criteria:
- ASPECTS score <6 on non-contrast CT (if patient is enrolled based on CT perfusioncriteria)
- Evidence of intracranial tumor (except small meningioma), acute intracranialhemorrhage, neoplasm, subarachnoid hemorrhage, or arteriovenous malformation
- Significant mass effect with midline shift
- Evidence of internal carotid artery dissection
- Intracranial stent implanted in the same vascular territory, known history of arterialtortuosity, and/or other arterial disease that precludes the safe deployment/removalof the thrombectomy device
Study Design
Total Participants: 55
Study Start date:
August 01, 2018
Estimated Completion Date:
August 01, 2026
Study Description
Connect with a study center
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang 310009
ChinaActive - Recruiting
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