Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058537) titled 'Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke with Occlusion of
the M2 Segment of Middle Cerebral Artery' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Hyogo Medical University
Condition:
Condition - Acute Ischemic Stroke with Occlusion of the M2 Segment of Middle Cerebral Artery
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the efficacy of endovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Medical therapy+Endovascular therapy
Interventions/Control_2 - Medical therapy alone
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - (1) Acute cerebral infarction
(2) Aged 18-84 years
(3) NIHSS score at admission 8 or more
(4) Prestroke mRS scores of 0-1
(5) Occlusion of the M2 segment of MCA on digital subtraction angiography (DSA)
(6) ASPECTS 8 or more, or DWI-ASPECTS 8 or more
(7) Ineligible or failed IV-tPA (no recanalization within 30 minutes after injection)
(8) Randomization can be completed within 24 hours from the last known well time.
(9) EVT can be initiated within 30 minutes from randomization.
(10) The patient or their legally authorized representative has signed the informed consent form.
Key exclusion criteria - (1) Occlusion of the anterior temporal artery, duplicate M1, or accessory M1
(2) Occlusion of multiple major intracranial arteries
(3) Difficulty in endovascular access due to tortuous vascular anatomy
(4) Significant mass effect with midline shift on CT (or MRI)
(5) Known allergy (more severe than skin rash) to contrast agents
(6) Evidence of acute intracranial hemorrhage on CT (or MRI)
(7) Pregnant or potentially pregnant
(8) Clinical evidence of chronic occlusion
(9) High risk of hemorrhage (platelet 50 second or PT-INR > 3.0)
(10) Participating in any other therapeutic investigational trial
(11) Judgment of the investigator to be non-compliant or uncooperative during the study
Target Size - 200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 22 Day
Anticipated trial start date - 2025 Year 10 Month 01 Day
Last follow-up date - 2028 Year 01 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066936
Disclaimer: Curated by HT Syndication.
