The purpose of this study is to investigate the safety and efficacy of endovascular treatment with or without preceding intravenous Tenecteplase in patients with late-window (4.5-24 hours of symptom onset) acute ischemic stroke due to middle cerebral artery (MCA) M1 or proximal M2 occlusion.
After being informed about the study and potential risks, patients who meet the inclusion criteria will be randomized to endovascular treatment with preceding intravenous Tenecteplase (0.25mg/kg, maximum 25mg) or without preceding intravenous Tenecteplase in a 1:1 ratio. Written informed consent will be needed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
391
Tenecteplase (0.25 mg/kg, maximum dose 25mg) is given as a single, intravenous bolus (injection over 5 to 10 seconds) immediately upon randomization. EVT should be performed as soon as possible after Tenecteplase administration.
During the study period, NMPA-approved stents are permitted. EVT included thrombectomy with stent retrievers, thromboaspiration, intraarterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team.
The First Affiliated Hospital of USTC
Hefei, Anhui, China
First Affiliated Hospital of Wannan Medical College
The modified Rankin Scale (mRS) score 0 to 2 at 90 days
The proportion of the modified Rankin Scale (mRS) score 0 to 2 at 90 days. Scores on the mRS range from 0 to 6, with higher scores indicating greater disability.
Time frame: 90 days
Ordinal shift analysis of mRS at 90 days (not combined mRS 5 and 6)
Ordinal shift analysis of mRS at 90 days (not combined mRS 5 and 6). Scores on the mRS range from 0 to 6, with higher scores indicating greater disability.
Time frame: 90 days
mRS 0-1 at 90 days
The proportion of mRS score 0 - 1 at 90 days. Scores on the mRS range from 0 to 6, with higher scores indicating greater disability.
Time frame: 90 days
mRS 0-3 at 90 days
The proportion of mRS 0 - 3 at 90 days. Scores on the mRS range from 0 to 6, with higher scores indicating greater disability.
Time frame: 90 days
mRS 5-6 at 90 days
The proportion of mRS 5 - 6 at 90 days. Scores on the mRS range from 0 to 6, with higher scores indicating greater disability.
Time frame: 90 days
NIHSS≤1 or a decrease of 8 points or more from baseline at 72h after randomization
NIHSS≤1 or a decrease of 8 points or more from baseline at 72h after randomization. Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating a greater deficit.
Time frame: 72 hours
Change in stroke severity (NIHSS score) at 7 days after randomization from baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Wuhu, Anhui, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Daxing District People's Hospital
Beijing, Beijing Municipality, China
The 2nd affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Puyang Oilfield General Hospital
Puyang, Henan, China
People's Hospital of Queshan
Zhumadian, Henan, China
First People's Hospital of Chenzhou
Chenzhou, Hunan, China
Dalian Municipal Central Hospital
Dalian, Liaoning, China
First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, China
...and 11 more locations
Change in stroke severity (NIHSS score) at 7 days after randomization from baseline. Scores on the NIHSS range from 0 to 42, with higher scores indicating a greater deficit.
Time frame: 7 days
Successful reperfusion prior to endovascular treatment by DSA (eTICI 2b50-3)
Successful reperfusion prior to endovascular treatment by DSA (expanded Treatment in Cerebral Infarction\[eTICI\] 2b50-3)
Time frame: 0 hours (at treatment time)
Complete recanalization according to CTA or MRA performed 24 hours after randomization
Complete recanalization according to CTA or MRA performed 24 hours after randomization (arterial occlusive lesion score \[AoL\]; scale range, 0 \[no recanalization\] to 3 \[complete recanalization\]).
Time frame: 24 hours
Good reperfusion at 24h after randomization
Good reperfusion at 24h after randomization (Tmax\>6s improved by 90% compared with before)
Time frame: 24 hours