Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery Occlusion: a Multi-center, Prospective, Open-label, Blinded Endpoint (PROBE), Phase 3, Randomized Controlled Trial
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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 M2 occlusion.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age≥18 years old.
• Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrollment including wake-up stroke and unwitnessed stroke; Onset time refers to 'last seen well time'.
• MCA-M1 or M2 occlusions confirmed by Computer Tomography Angiography (CTA)/Magnetic Resonance Angiography (MRA) that was responsible for signs and symptoms of acute ischemic stroke.
• Neuroimaging: target mismatch profile on CT perfusion (CTP) or MRI + perfusion weighted imaging (PWI) (analyzed by perfusion analysis software with Class II and above medical device certificates) \[ischemic core volume (defined as CBF\<30%) \<70mL, mismatch ratio≥1.8, mismatch volume≥15mL\].
• Pre-stroke mRS score ≤2.
• Baseline NIHSS 6-25 (both included).
• Written informed consent from patients or their legally authorized representative.
Locations
Other Locations
China
Beijing Tiantan Hospital, Capital Medical University
ACTIVE_NOT_RECRUITING
Beijing
Heze Municipal Hospital
ACTIVE_NOT_RECRUITING
Heze
Liaocheng Third People's Hospital
ACTIVE_NOT_RECRUITING
Liaocheng
Linfen Central Hospital
ACTIVE_NOT_RECRUITING
Linfen
Linyi People's Hospital
RECRUITING
Linyi
Eastern Theater General Hospital
ACTIVE_NOT_RECRUITING
Nanjing
Qingdao Central Hospital
ACTIVE_NOT_RECRUITING
Qingdao
Rizhao People's Hospital
ACTIVE_NOT_RECRUITING
Rizhao
Rizhao Traditional Chinese Medicine Hospital
ACTIVE_NOT_RECRUITING
Rizhao
First Affiliated Hospital of Xi 'an Jiaotong University
ACTIVE_NOT_RECRUITING
Xi'an
Contact Information
Primary
Yunyun Xiong, MD
xiongyunyun@bjtth.org
15710088948
Time Frame
Start Date:2023-12-16
Estimated Completion Date:2025-05
Participants
Target number of participants:390
Treatments
Experimental: IVT with rhTNK-tPA+EVT
rhTNK-tPA 0.25mg/kg: 1-2 vials (1.0×107 IU/16 mg per vial) Each vial of rhTNK-tPA is reconstituted with 3 ml sterile water for injection and adjusted to a concentration of 5.33 mg/ml. The total amount of drug will be calculated according to the subject's actual body weight and the required drug volume will be measured. The maximum dose should not exceed 25mg. rhTNK-tPA should be given as a single, intravenous bolus (drug administered over 5-10 seconds).~Endovascular treatment (EVT) should be performed as soon as possible after rhTNK-tPA administration.
Active_comparator: Direct EVT
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.