Acute Ischemic StrokeBAOCHE2NCT06560203
Basilar Artery Occlusion Chinese Endovascular Trial in the Extended Time Window
A study testing Mechanical thrombectomy in people with Acute Ischemic Stroke and Basilar Artery Occlusion, run by Capital Medical University at 1 site in China.
Trial summary
A prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial to evaluate the safety and efficacy of endovascular mechanical thrombectomy for acute basilar artery occlusion in the extended time window Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke, Basilar Artery Occlusion
- What is being tested?
- Mechanical thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2024to 30 Jun 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Posterior circulation acute ischemic stroke within 24-72 hours from symptom onset/last seen well (except for isolated vertigo), where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., patient presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without recanalization.
- Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.
- Age ≥18 and ≤ 80.
- Baseline NIHSS score obtained prior to randomization must be equal or higher than 6 points.
- No significant pre-stroke functional disability (mRS ≤ 1).
- 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.
- Informed consent obtained from patient or authorized patient surrogate
Who cannot join
- Clinical criteria
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0.
- Baseline platelet count < 50000/µL.
- Baseline blood glucose of < 50mg/dL or >400mg/dl.
- 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.
- Patients in whom baseline NIHSS can not be obtained by a neurologist or emergency physician prior to sedation or intubation.
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- Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
- Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
- History of life threatening allergy (more than rash) to contrast medium.
- Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery .
- Renal insufficiency with creatinine ≥ 3 mg/dl.
- Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
- Subject participating in a study involving an investigational drug or device that would impact this study.
- Known diagnosis or clinical suspicion of cerebral vasculitis.
- 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.).
- Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).
- 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
- 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.
- CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed).
- Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the fourth ventricle.
- Complete bilateral thalamic infarction on CT or MRI.
- 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.
- Subjects with occlusions in both anterior and posterior circulation.
- Evidence of intracranial tumor (except small meningioma).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu hospital
Beijing, Beijing Municipality, 100053
Chuanhui Li, 15210439828, lichuanhui365@163.com
Xunming Ji, 01083198962, jixm@ccmu.edu
About this study
Official title: Safety and Efficacy of Endovascular Treatment for Acute Basilar Artery Occlusion in the Extended Time Window -a Prospective, Multicenter, Randomized Controlled, Open-label Clinical Trial
A prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial to evaluate the safety and efficacy of endovascular mechanical thrombectomy for acute basilar artery occlusion in the extended time window
Read the detailed description
This trial aims to evaluate the hypothesis that mechanical thrombectomy is superior to medical management alone in achieving favorable outcomes in subjects presenting with stroke due to basilar artery occlusion in the extended time window of 24-72 hours from symptom onset or time last seen well. In this trial, the randomization will employ a 2:1 ratio of mechanical thrombectomy versus best medical management alone. Randomization will be stratified according to age (18-70 or >70), baseline NIHSS (6-20 or >20) and therapeutic window (24-48 hours or >48 hours). For the primary endpoint, subjects will be followed for 90 days post-randomization.
- Conditions
- Acute Ischemic Stroke, Basilar Artery Occlusion
- Being tested
- Mechanical thrombectomy
- Keywords
- Mechanical thrombectomy, Extended time window
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical thrombectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| mechanical thrombectomy group | Experimental | 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. Receives: Procedure: Mechanical thrombectomy |
| best medical management agroup | No intervention | Best Medical Treatment and maximum supportive care according to local guidelines, not including mechanical thrombectomy, no intra-arterial treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in proportion of patients achieving favorable outcomes (defined as mRS 0-3) at 90 days
The modified Rankin scale (range, 0 [no symptoms] to 6 [death])
Measured: 90 days
Secondary outcomes (8)
Dramatic early favorable response
Dramatic early favorable response as determined by an National Institute of Health stroke scale (NIHSS) of 0-2 or NIHSS improvement ≥ 8 points at 24 (-2/+12) hours.
Measured: 24 (-2/+12) hours
Dichotomized mRS score (0-2 versus 3-6 )
The modified Rankin scale (range, 0 [no symptoms] to 6 [death])
Measured: 90 days
Ordinal Shift analysis of mRS at 90 days
The modified Rankin scale (range, 0 [no symptoms] to 6 [death])
Measured: 90 days
Barthel Index at 90 days
An ordinal scale which measures a person's ability to complete activities of daily living (ADL).
Measured: 90 days
Quality of life analysis as measured by EuroQol Five Dimensions (EuroQol/EQ-5D)
EuroQol Five Dimensions (EuroQol/EQ-5D) is a well-known and widely used health status instrument, and could be used to measure, compare and value health status across disease areas.
Measured: 90 days
Difference in proportion of patients with mRS 0-2 scores between the two groups at 12 months.
The modified Rankin scale (range, 0 [no symptoms] to 6 [death])
Measured: 12 months
Difference in proportion of patients with mRS 0-3 scores between the two groups at 12 months.
The modified Rankin scale (range, 0 [no symptoms] to 6 [death])
Measured: 12 months
Proportion of basilar artery recanalization
Vessel recanalization evaluated by CT angiography (CTA), MR Angiography (MRA) or conventional angiography at 24-72 hours in both treatment groups assessed by Arterial Occlusive Lesion（AOL) grades and adjudicated by a central core-lab.
Vessel recanalization post procedure in the thrombectomy arm assessed by mTICI grades. Successful recanalization is defined as mTICI (Modified Thrombolysis in Cerebral Infarction) 2b or 3 on the post-procedure angiogram.
Measured: 24-72 hours (both treatment groups); post procedure immediately (thrombectomy arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start10 Sep 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 309 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
- Investigators
- Xunming Ji, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560203
- Sponsor's protocol ID
- BAOCHE-2
- Acronym
- BAOCHE2
- Status last verified
- Sep 2024
- First submitted
- 15 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is proceeding.
Publications
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.
PubMed 36239645Tao 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.
PubMed 36239644Kobeissi 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.
PubMed 37140919Purrucker 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.
PubMed 35646160Pandhi 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.
PubMed 36893513Markus 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.
PubMed 38420839Dhillon 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.
PubMed 35169031Rodriguez-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.
PubMed 37355251Shaban 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.
PubMed 36593118Liu 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.
PubMed 36550266Mohamed 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.
PubMed 37282375Sarraj 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.
PubMed 33563012Christensen 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.
PubMed 30735466