Endovascular Thrombectomy With and Without Intravenous Thrombolysis in Extended Time Window
1 other identifier
interventional
222
1 country
1
Brief Summary
The primary hypothesis being tested in this trial is that ischemic stroke patients in large vessel occlusion of anterior circulation at 4.5 - 9 hours post onset of stroke will have improved clinical outcomes when given endovascular thrombectomy with intravenous thrombolysis compared with that of given direct endovascular thrombectomy alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2022
CompletedFirst Posted
Study publicly available on registry
December 2, 2022
CompletedStudy Start
First participant enrolled
December 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedFebruary 14, 2023
February 1, 2023
2 years
November 21, 2022
February 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Good clinical outcome
Score in modified Rankin Scale (mRS) ≤ 2 (mRS is short for modified ranking score, with minimum value of 0 and maximum value of 6. Higher score means a worse outcome.)
90 days after randomization
Secondary Outcomes (8)
Mortality
90 days after randomization
Modified Rankin Scale (mRS) shift analysis
day 0 and 90 days after randomization
National Institute of Health Score Scale (NIHSS)
day 0 and day 1 after randomization
Thrombolysis in Cerebral Infarction (TICI) scale
day 0 and day 1 after randomization
Serious adverse events
day 0 until 90 days after randomization
- +3 more secondary outcomes
Study Arms (2)
Intravenous thrombolysis bridging with endovascular thrombectomy
EXPERIMENTALDirect endovascular thrombectomy without intravenous thrombolysis
ACTIVE COMPARATORInterventions
Intravenous thrombolysis with recombinant tissue-type plasminogen activator (rt-PA，alteplase) or TNK-tPA (Tenecteplase，Metalyse)
endovascular mechanical thrombectomy with nonspecific device
Eligibility Criteria
You may qualify if:
- Patient/Legally Authorized Representative has signed the Informed Consent form
- Age ≥ 18
- Clinical signs consistent with an acute ischemic stroke
- Neurological deficit with a NIHSS of ≥ 6 (deficits judged to be clearly disabling at presentation)
- Patient is eligible for intravenous thrombolysis
- Patient is eligible for endovascular treatment
- Randomization no later than 8 hours 45 minutes after stroke symptom onset and initiation of IV t-PA must be started within 9 hours of stroke symptoms onset (for stroke with unknown time of onset, the midpoint of the time last known to be well and symptom recognition time)
- ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA or CTA (including the reconstructed CTA derived from CTP). And target Mismatch Profile on CT perfusion or MRI (ischemic core volume is \< 70 ml, mismatch ratio is \>/= 1.8 and mismatch volume is \>/= 15 ml)
- Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 based on baseline CT or MR imaging (MRI) (a region has to have diffusion abnormality in 20% or more of its volume to be considered MR-ASPECTS positive)
You may not qualify if:
- Acute intracranial hemorrhage
- Any contraindication for IV t-PA
- Pre-treatment with IV t-PA
- Pregnancy or lactating women. A negative pregnancy test before randomization is required for all women with child-bearing potential.
- Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals, or their alloys
- Known current participation in a clinical trial (investigational drug or medical device)
- Renal insufficiency as defined by a serum creatinine \> 2.0 mg/dl (or 176.8 µmol/l) or glomerular filtration rate (GFR) \< 30 mL/min or requirement for hemodialysis or peritoneal dialysis
- Severe comorbid condition with life expectancy less than 90 days at baseline
- Known advanced dementia or significant pre-stroke disability (mRS score of ≥2)
- Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)
- Comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments
- Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
- Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the femoral access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after MT
- Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma)
- Radiological confirmed evidence of cerebral vasculitis
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Min Lou, Professor
Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2022
First Posted
December 2, 2022
Study Start
December 3, 2022
Primary Completion
November 28, 2024
Study Completion
February 28, 2025
Last Updated
February 14, 2023
Record last verified: 2023-02