Basilar Artery Occlusion Chinese Endovascular Trial in the Extended Time Window
NCT ID: NCT06560203
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
309 participants
INTERVENTIONAL
2024-09-10
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Endovascular Treatment for Acute Basilar Artery Occlusion
NCT04751708
Basilar Artery Occlusion Chinese Endovascular Trial
NCT02737189
Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Thrombectomy on Acute Basilar Artery Occlusion
NCT05827042
Trial of Rescue Endovascular Treatment for Progressive Acute Mild Ischemic Stroke With Basilar Artery Occlusion With Extended Time Window
NCT06843356
A Comparison of Contact Aspiration Versus Stent Retriever for Acute Basilar Artery Occlusion
NCT05615038
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
mechanical thrombectomy group
Researchers can choose to deal with the stenosis or occlusion of blood vessels according to their own judgment, including stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods.
Mechanical thrombectomy
Neurointerventionist determine whether to proceed with interventional therapy after assessing the location and degree of occlusion, the tortuosity of the access vessel, and the presence of stenosis or occlusion in the proximal artery. In cases where there is no proximal stenosis or occlusion, mechanical thrombectomy is performed, and the specific thrombectomy strategy is tailored by the researcher based on the patient's condition. For lesions associated with proximal vascular stenosis or occlusion, it is necessary to navigate the catheter through the proximal stenosis or occlusion to access the intracranial occlusion. Researchers have the discretion to treat the stenotic or occluded vessels, which may include options such as no treatment, stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods.
best medical management agroup
Best Medical Treatment and maximum supportive care according to local guidelines, not including mechanical thrombectomy, no intra-arterial treatment.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mechanical thrombectomy
Neurointerventionist determine whether to proceed with interventional therapy after assessing the location and degree of occlusion, the tortuosity of the access vessel, and the presence of stenosis or occlusion in the proximal artery. In cases where there is no proximal stenosis or occlusion, mechanical thrombectomy is performed, and the specific thrombectomy strategy is tailored by the researcher based on the patient's condition. For lesions associated with proximal vascular stenosis or occlusion, it is necessary to navigate the catheter through the proximal stenosis or occlusion to access the intracranial occlusion. Researchers have the discretion to treat the stenotic or occluded vessels, which may include options such as no treatment, stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.
3. Age ≥18 and ≤ 80.
4. Baseline NIHSS score obtained prior to randomization must be equal or higher than 6 points.
5. No significant pre-stroke functional disability (mRS ≤ 1).
6. Patient treatable within 72 hours of symptom onset. Symptom onset is defined as the point in time the patient was last seen well (at baseline) if patients are unable to provide a reliable history or the point in time when symptoms have started if patients can provide a reliable history.
7. Informed consent obtained from patient or authorized patient surrogate
Exclusion Criteria
1. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0.
2. Baseline platelet count \< 50000/µL.
3. Baseline blood glucose of \< 50mg/dL or \>400mg/dl.
4. Severe, sustained hypertension (SBP \> 220 mm Hg or DBP \> 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained below these levels using commonly used medications in China for these purposes (including iv antihypertensive drips), the patient can be enrolled.
5. Patients in whom baseline NIHSS can not be obtained by a neurologist or emergency physician prior to sedation or intubation.
6. Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
7. Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
8. History of life threatening allergy (more than rash) to contrast medium.
9. Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery .
10. Renal insufficiency with creatinine ≥ 3 mg/dl.
11. Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
12. Subject participating in a study involving an investigational drug or device that would impact this study.
13. Known diagnosis or clinical suspicion of cerebral vasculitis.
14. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.).
15. Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).
16. Any other condition that, in the opinion of the investigator will pose a significant hazard to the subject if participating in the trial.
Neuroimaging criteria
17. Hypodensity with a posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) \< 6 and Pons-midbrain-index of ≥ 3 on CT angiography source images or MR with diffusion-weighted imaging or non-contrast CT.
18. CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed).
19. Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the fourth ventricle.
20. Complete bilateral thalamic infarction on CT or MRI.
21. Evidence of vertebral occlusion, high grade stenosis or arterial dissection in the extracranial or intracranial segment that cannot be treated or will prevent access to the intracranial clot or excessive tortuosity of cervical vessels precluding device delivery/deployment.
22. Subjects with occlusions in both anterior and posterior circulation.
23. Evidence of intracranial tumor (except small meningioma).
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Capital Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ji Xunming,MD,PhD
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xunming Ji
Role: PRINCIPAL_INVESTIGATOR
Xuanwu Hospital, Beijing
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Xuanwu hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Jovin TG, Li C, Wu L, Wu C, Chen J, Jiang C, Shi Z, Gao Z, Song C, Chen W, Peng Y, Yao C, Wei M, Li T, Wei L, Xiao G, Yang H, Ren M, Duan J, Liu X, Yang Q, Liu Y, Zhu Q, Shi W, Zhu Q, Li X, Guo Z, Yang Q, Hou C, Zhao W, Ma Q, Zhang Y, Jiao L, Zhang H, Liebeskind DS, Liang H, Jadhav AP, Wen C, Brown S, Zhu L, Ye H, Ribo M, Chang M, Song H, Chen J, Ji X; BAOCHE Investigators. Trial of Thrombectomy 6 to 24 Hours after Stroke Due to Basilar-Artery Occlusion. N Engl J Med. 2022 Oct 13;387(15):1373-1384. doi: 10.1056/NEJMoa2207576.
Tao C, Nogueira RG, Zhu Y, Sun J, Han H, Yuan G, Wen C, Zhou P, Chen W, Zeng G, Li Y, Ma Z, Yu C, Su J, Zhou Z, Chen Z, Liao G, Sun Y, Ren Y, Zhang H, Chen J, Yue X, Xiao G, Wang L, Liu R, Liu W, Liu Y, Wang L, Zhang C, Liu T, Song J, Li R, Xu P, Yin Y, Wang G, Baxter B, Qureshi AI, Liu X, Hu W; ATTENTION Investigators. Trial of Endovascular Treatment of Acute Basilar-Artery Occlusion. N Engl J Med. 2022 Oct 13;387(15):1361-1372. doi: 10.1056/NEJMoa2206317.
Kobeissi H, Ghozy S, Adusumilli G, Kadirvel R, Brinjikji W, Rabinstein AA, Kallmes DF. Endovascular Therapy for Stroke Presenting Beyond 24 Hours: A Systematic Review and Meta-analysis. JAMA Netw Open. 2023 May 1;6(5):e2311768. doi: 10.1001/jamanetworkopen.2023.11768.
Purrucker JC, Ringleb PA, Seker F, Potreck A, Nagel S, Schonenberger S, Berberich A, Neuberger U, Mohlenbruch M, Weyland C. Leaving the day behind: endovascular therapy beyond 24 h in acute stroke of the anterior and posterior circulation. Ther Adv Neurol Disord. 2022 May 25;15:17562864221101083. doi: 10.1177/17562864221101083. eCollection 2022.
Pandhi A, Chandra R, Abdulrazzak MA, Alrohimi A, Mahapatra A, Bain M, Moore N, Hussain MS, Bullen J, Toth G. Mechanical thrombectomy for acute large vessel occlusion stroke beyond 24 h. J Neurol Sci. 2023 Apr 15;447:120594. doi: 10.1016/j.jns.2023.120594. Epub 2023 Mar 2.
Markus HS. Reperfusion therapy for stroke: From improving global access, to thrombectomy beyond 24 hours. Int J Stroke. 2024 Mar;19(3):248-250. doi: 10.1177/17474930241232131. No abstract available.
Dhillon PS, Butt W, Podlasek A, Barrett E, McConachie N, Lenthall R, Nair S, Malik L, James MA, Dineen RA, England TJ. Endovascular thrombectomy beyond 24 hours from ischemic stroke onset: a propensity score matched cohort study. J Neurointerv Surg. 2023 Mar;15(3):233-237. doi: 10.1136/neurintsurg-2021-018591. Epub 2022 Feb 15.
Rodriguez-Calienes A, Galecio-Castillo M, Vivanco-Suarez J, Mohamed GA, Toth G, Sarraj A, Pujara D, Chowdhury AA, Farooqui M, Ghannam M, Samaniego EA, Jovin TG, Ortega-Gutierrez S. Endovascular thrombectomy beyond 24 hours from last known well: a systematic review with meta-analysis. J Neurointerv Surg. 2024 Jun 17;16(7):670-676. doi: 10.1136/jnis-2023-020443.
Shaban A, Al Kasab S, Chalhoub RM, Bass E, Maier I, Psychogios MN, Alawieh A, Wolfe SQ, Arthur AS, Dumont TM, Kan P, Kim JT, De Leacy R, Osbun JW, Rai AT, Jabbour P, Park MS, Crosa RJ, Mascitelli JR, Levitt MR, Polifka AJ, Casagrande W, Yoshimura S, Matouk C, Williamson R, Gory B, Mokin M, Fragata I, Romano DG, Chowdhry SA, Moss M, Behme D, Limaye K, Spiotta AM, Samaniego EA. Mechanical thrombectomy for large vessel occlusion strokes beyond 24 hours. J Neurointerv Surg. 2023 Dec 21;15(e3):e331-e336. doi: 10.1136/jnis-2022-019372.
Liu S, Cao W, Wu L, Wen A, Zhou Y, Xiang Z, Rao W, Yao D. Endovascular treatment over 24 hours after ischemic stroke onset: a single-center retrospective study. Neuroradiology. 2023 Apr;65(4):793-804. doi: 10.1007/s00234-022-03105-6. Epub 2022 Dec 23.
Mohamed GA, Nogueira RG, Essibayi MA, Aboul-Nour H, Mohammaden M, Haussen DC, Ruiz AM, Gross BA, Kuybu O, Salem MM, Burkhardt JK, Jankowitz B, Siegler JE, Patel P, Hester T, Ortega-Gutierrez S, Farooqui M, Galecio-Castillo M, Nguyen TN, Abdalkader M, Klein P, Charles JH, Saini V, Yavagal DR, Jumah A, Alaraj A, Peng S, Hafeez M, Tanweer O, Kan P, Scaggiante J, Matsoukas S, Fifi JT, Mayer SA, Chebl AB. Tissue Clock Beyond Time Clock: Endovascular Thrombectomy for Patients With Large Vessel Occlusion Stroke Beyond 24 Hours. J Stroke. 2023 May;25(2):282-290. doi: 10.5853/jos.2023.00017. Epub 2023 May 30.
Sarraj A, Mlynash M, Heit J, Pujara D, Lansberg M, Marks M, Albers GW. Clinical Outcomes and Identification of Patients With Persistent Penumbral Profiles Beyond 24 Hours From Last Known Well: Analysis From DEFUSE 3. Stroke. 2021 Mar;52(3):838-849. doi: 10.1161/STROKEAHA.120.031147. Epub 2021 Feb 10.
Christensen S, Mlynash M, Kemp S, Yennu A, Heit JJ, Marks MP, Lansberg MG, Albers GW. Persistent Target Mismatch Profile >24 Hours After Stroke Onset in DEFUSE 3. Stroke. 2019 Mar;50(3):754-757. doi: 10.1161/STROKEAHA.118.023392.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BAOCHE-2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.