Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
NCT Number: NCT06580730
Acute ischemic stroke (AIS) is one of the leading causes of disability and mortality worldwide. The treatment of this condition is time-critical, with the key to effective therapy being the early recanalization of the occluded vessel and restoration of blood flow to salvage the ischemic penumbra tissue. Currently, the time window for endovascular treatment in the anterior circulation can be extended up to 24 hours. Exploring endovascular treatments for patients beyond this time window (from 24 hours to 30 days) could mean hope for a greater number of AIS patients.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Wuhan, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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Exclusion criteria
Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revascularization should be performed with the operators standard thrombectomy technique using aspiration or a stent retriever, separately or in combination.
Other names: mechanical revascularization
Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician.
Time frame: 90days
Modified Rankin Scale:1. Total asymptomatic score 0 2, despite symptoms, but no obvious dysfunction, can complete all daily work and life score 1 Mildly disabled, unable to complete all pre-illness activities, but able to take care of daily tasks without assistance score 2 3, moderate disability, need some help, but can walk independently score 3 4, moderate to severe disability, can not walk independently, daily life needs help from others score 4 5, severe disability, bed rest, urinary incontinence, daily life completely dependent on others score 5 6. Death score 6
Time frame: 90days
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. 0 - No symptoms.
Time frame: 90days
Assessment on the 90th day via MRA or CTA
Time frame: 90days
Barthel Index
Time frame: 2-7days
Defined as a decrease of ≥4 points from baseline in NIHSS or an NIHSS score of 0 or 1
Time frame: 24hours
Assessment of the infarct volume through imaging (MRI)
Time frame: 24hours
assessed by MRA/CTA
Time frame: 90days
EQ-5D-5L Scales
Time frame: 90days
Montreal Cognitive Assessment (MoCA)
Time frame: 90days
Mini-Mental State Examination (MMSE)
Time frame: 90days
Time frame: 90days
Time frame: 90days
The patient had a transient ischemic attack, symptoms of cerebral infarction, or the presence of cerebral infarction confirmed by imaging
Time frame: 24hours
Defined as a worsening of 4 or more points on the NIHSS within 24 (-6/+24) hours post-randomization and associated with cerebral hemorrhage
Time frame: 24hours
Substantial hematoma type 2, accounting for more than 30% of the infarct area, with associated space-occupying effect and leading to clinical condition deterioration
Time frame: 2-7days
Defined as an increase of ≥4 points in NIHSS score from baseline
Time frame: Post procedure 24hours
according to the ASITN/SIR collateral grading scale
Time frame: Post procedure 24hours
a) Distal embolization in different regions; b) Iatrogenic arterial dissection; c) Arterial perforation; d) Access site complications of interventional treatment
Time frame: Post procedure 24hours
eTIMI grade ≥2b
Contact information is provided by the study sponsor or research team.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Other
Endovascular Treatment Post 1 Day (24 Hours): a Randomized Controlled Clinical Trial on Efficacy and Safety for Stroke
Acronym: ETP-1
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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