West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Location contact
Bo Wu
CONTACT
Fayun Hu, Dr.
CONTACT
NCT Number: NCT07336927
IAT-MeVO is an international, multicenter, prospective, randomised, open-label, blinded end-point assessed (PROBE) trial, to evaluate the efficacy and safety of endovascular therapy (EVT) [intra-arterial thrombolysis (IAT)-based] versus best medical management (BMT) in patients with acute ischemic stroke (AIS) due to medium vessel occlusion (MeVO) who are ineligible for intravenous thrombolysis (IV) within 24 h of onset.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Chengdu, Sichuan, 610041, China
Bo Wu
CONTACT
Fayun Hu, Dr.
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive IAT-based EVT in addition to medical treatment. IAT with TNK will be performed first. If adequate dosing fails to achieve reperfusion, the surgical team may evaluate the need for aspiration or stent retriever thrombectomy. For second-order branches (M2/A1/P1 segments), the number of retrieval attempts must not exceed three; for third-order branches (M3/A2/P2 and beyond), no more than two attempts are allowed.
*Arterial thrombolysis protocol: Dose: 0.125 mg/kg body weight, maximum 12.5 mg
*No restrictions will be placed on the choice of aspiration catheters or stent retrievers used in this study.
Time frame: 90 days
The proportion of patients with an modified Rankin Scale (mRS) score of 0-1. The mRS is a clinician-reported measure of global disability widely used to assess outcomes in patients with stroke and other neurological disorders. It ranges from 0 (no symptoms) to 6 (death).
Time frame: 90 days
The proportion of patients with an modified Rankin Scale (mRS) score of 0-2. The mRS is a clinician-reported measure of global disability widely used to assess outcomes in patients with stroke and other neurological disorders. It ranges from 0 (no symptoms) to 6 (death).
Time frame: 90 days
The modified Rankin Scale (mRS) score at 90 days and the utility weighted mRS. The mRS is a clinician-reported measure of global disability widely used to assess outcomes in patients with stroke and other neurological disorders. It ranges from 0 (no symptoms) to 6 (death).
Time frame: 90 days
Quality of life measured using EQ-5D-5L.The EuroQol 5-Dimension 5-Level instrument (EQ-5D-5L) is a generic, preference-based measure of health-related quality of life. It generates two primary scores: 1) a utility index score (typically ranging from -0.573 to 1.00, depending on the value set, where 1 represents 'full health'), and 2) a self-rated Visual Analog Scale (EQ-VAS) score (ranging from 0 to 100). For both scores, a higher value indicates a better health outcome.
Time frame: 72±12 hours
Neurological status measured by National Institutes of Health Stroke Scale (NIHSS) score. The National Institutes of Health Stroke Scale (NIHSS) is a standardized 15-item neurologic examination tool used to quantify the severity of acute cerebral infarction. Scores range from 0 to 42, with higher scores indicating more severe neurological deficit.
Time frame: 72±12 hours
Achieving an NIHSS score of 0-1 or a decrease of ≥4 points from the baseline NIHSS score. The National Institutes of Health Stroke Scale (NIHSS) is a standardized 15-item neurologic examination tool used to quantify the severity of acute cerebral infarction. Scores range from 0 to 42, with higher scores indicating more severe neurological deficit.
Time frame: 24-72 hours
Final infarct size based on CT or MRI
Time frame: 7 days
sICH defined by SIST-MOST criteria
Time frame: 7 days
Any intracranial hemorrhage was a key safety outcome, encompassing any acute bleeding within the cranial cavity. All suspected events were confirmed by follow-up CT or MRI scans.
Time frame: 7 days
The incidence of malignant edema, adjudicated by the central imaging core lab according to follow-up imaging and medical history
Time frame: 7 days
Death
Time frame: 90 days
Death
Time frame: 4 days
adverse events post-EVT
Contact information is provided by the study sponsor or research team.
Bo Wu
Other
Efficacy and Safety of Endovascular Therapy With Intra-Arterial Thrombolysis for Medium Vessel Occlusion Stroke--the IAT-MeVO Trial
Acronym: IAT-MeVO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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