Endovascular Treatment for Acute Basilar Artery Occlusion

• ClinicalTrials.gov Identifier: NCT04751708
• Recruitment Status: Recruiting
• First Posted: February 12, 2021
• Last Update Posted: June 14, 2021
• Sponsor: The First Affiliated Hospital of University of Science and Technology of China
• Information provided by (Responsible Party): Wei Hu, The First Affiliated Hospital of University of Science and Technology of China

Study Description

Brief Summary:

Rationale: Recently, two prospective multicenter RCT reported a potential beneficial effect of endovascular thrombectomy (EVT) in patients with an acute symptomatic basilar artery occlusion (BAO). However, the high rate of crossover in BEST study and the long-term of recruitment in BASICS study influenced the validity of the results. Besides, a recently prospective clinical registry with large sample size (BASILAR) showed a significantly beneficial effect of EVT in BAO patients.

Objective: To assess the effect of EVT in addition to best medical management (BMM) compared to BMM alone, in patients with BAO, caused by a CTA/MRA confirmed occlusion of the basilar artery on functional and safety outcome.

Study design: This is a parallel group, randomized clinical trial of EVT with BMM versus BMM. The trial has observer blind assessment of the primary outcome and of neuro-imaging at baseline and follow up.

Study population: Patients with acute ischemic stroke and a confirmed basilar artery occlusion by CTA/MRA.

Main study parameters/outcomes: The primary effect parameter will be favourable outcome at day 90 defined as a modified Rankin Score (mRS) of 0-3. The estimate will be adjusted for the known prognostic variables age, pre-stroke mRS, time from onset to randomization, stroke severity (NIHSS) and collaterals and adjusted and unadjusted estimates with corresponding 95% confidence intervals will be reported.

Condition or disease	Intervention/treatment	Phase
Basilar Artery Occlusion; Acute Cerebrovascular Accident; Stroke Due to Basilar Artery Occlusion	Procedure: endovascular treatment; Other: best medical management	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 342 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Endovascular Treatment for Acute Basilar Artery Occlusion - a Multicenter Randomized Clinical Trial
• Actual Study Start Date: February 21, 2021
• Estimated Primary Completion Date: February 2023
• Estimated Study Completion Date: May 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: best medical management; Unless contra-indicated patients are treated with a standard full dose of open-label IV rt-PA (0.9mg/kg; 90mg maximum). IVT has to be initiated within 4.5 hours of estimated time of basilar artery occlusion. For the patients in whom the rtPA is contraindicated, the standard medical treatment follows the current guidelines for the early management of patients with acute ischemic stroke from the American Heart Association/American Stroke Association.	Other: best medical management; best medical management
Experimental: endovascular treatment+ best medical management; Device: endovascular treatment For patients randomized to endovascular treatment arm, EVT has to be initiated within 12 hours of estimated time of basilar artery occlusion. If an appropriate thrombus or residual stenosis is identified, the choice of EVT strategy will be made by the treating neurointerventionalist. The endovascular procedures allowed by the steering committee include mechanical thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, or any combination of above procedures. We recommend applying ADAPT as the first choice of treatment. All mechanical thrombectomy devices for EVT, which are approved by CFDA for this purpose, are allowed in the trial.	Procedure: endovascular treatment; For patients randomized to endovascular treatment arm, EVT has to be initiated within 12 hours of estimated time of basilar artery occlusion. If an appropriate thrombus or residual stenosis is identified, the choice of EVT strategy will be made by the treating neurointerventionalist. The endovascular procedures allowed by the steering committee include mechanical thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, or any combination of above procedures. We recommend applying ADAPT as the first choice of treatment. All mechanical thrombectomy devices for EVT, which are approved by CFDA for this purpose, are allowed in the trial.

Outcome Measures

Primary Outcome Measures :

1. a modified Rankin Score of 0-3 [ Time Frame: 90 (± 14 days) after procedure ]
   Favourable outcome at day 90 (± 14 days)

Secondary Outcome Measures :

1. a modified Rankin Score of 0-2 [ Time Frame: 90 (± 14 days) after procedure ]
   Excellent outcome
2. Modified Rankin Score [ Time Frame: 90 (± 14 days) after procedure ]
   The mRS is an ordinal hierarchical scale ranging from 0 to 5, with higher scores indicating more severe disability.
3. NIHSS score [ Time Frame: 24 hours after procedure ]
   The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
4. NIHSS score [ Time Frame: 5-7 days after procedure ]
   The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
5. mortality [ Time Frame: 90 (± 14 days) after procedure ]
   (Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%
6. symptomatic intracerebral hemorrhage (ICH) [ Time Frame: within 72 hours after procedure ]
   SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 72 hours or any hemorrhage leading to death.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria

1. Symptoms and signs compatible with ischemia in the basilar artery territory；
2. Basilar artery occlusion confirmed by CTA/MRA/DSA；
3. Age of 18 years or older；
4. Time from stroke onset to randomization within 12 hours of estimated time of basilar artery occlusion (defined as the sudden onset of stroke symptoms consistent with acute occlusion of the basilar artery (e.g. not considering any previous minor prodromal symptoms) as adjudicated by two local experienced neurologists). If symptoms of sudden deterioration are not witnessed (e.g. wake-up or unwitnessed strokes) the time that the patient was last known to be without any major neurological deficits (such as moderate or severe weakness, stupor, coma) will be used as the time of stroke onset.
5. Written informed consent;
6. National Institutes of Health Stroke Scale (NIHSS) score ≥10 at the time of neuroimaging Exclusion criteria

1. Pre-existing dependency with mRS ≥3 for patients<80 years; premorbid mRS≥1 for patients≥80 years； 2. bilateral mydriasis; 3. Pregnancy; if a woman is of childbearing potential a urine or serum beta HCG test is positive; 4. Severe contrast allergy or absolute contraindication to iodinated contrast; 5. Participation in other clinical trials; 6. Systolic pressure >185 mmHg or diastolic pressure >110 mmHg, and cannot be controlled by antihypertensive drugs; 7. Known genetic or acquired bleeding constitution, lack of anticoagulant factors, or oral anticoagulant drugs and INR > 1.7; 8. Blood glucose < 2.7 or >22.2 mmol / L; platelet count < 50×109 / L, or hematocrit < 25%; 9. Life expectancy < 1 year； 10. Patients that cannot complete 90-day follow-up (e.g. no fixed residence, overseas patients, etc.)； 11. Acute ischemic cerebral infarction within 48 hours after major surgery (patients can be enrolled if more than 48 hours); 12. Premorbid cerebrovascular inflammation; 13. Premorbid nervous system disease or mental disorders hindering the assessment of the disease; Imaging exclusion criteria

1. CT/MR shows intracranial hemorrhage (patients with microbleeds on MR can be included if lesion diameter ≤5mm);
2. CTA/MRA/DSA shows the artery is seriously tortuous, variability or dissection, and thrombectomy device cannot reach the target vessel;
3. PC-ASPECTS on CT/CTA-Source Images/MRI-DWI <6 for patients<80 years (<8 for patients ≥80 years);
4. CT or MR shows the cerebellar infarction with obvious space occupying effect and obvious compression of the fourth ventricle;
5. Complete bilateral thalami or bilateral brainstem infarction confirmed by CT/MR;
6. Occlusion of both anterior and posterior circulation confirmed by CTA/MRA/DSA;
7. Intracranial tumors (except small meningiomas).

Contacts and Locations

Contacts

Contact: Wei Hu, MD, PhD; +86 055162284313; andinghu@ustc.edu.cn

Locations

China, Anhui

The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine; Recruiting

Hefei, Anhui, China, 239300

Contact: Wei Hu, PhD 8655162284076

Sponsors and Collaborators

The First Affiliated Hospital of University of Science and Technology of China

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hankey GJ. Endovascular Therapy for Acute Basilar Artery Occlusion. Circulation. 2022 Jul 5;146(1):18-20. doi: 10.1161/CIRCULATIONAHA.122.060571. Epub 2022 Jul 5.

Tao C, Li R, Zhu Y, Qun S, Xu P, Wang L, Zhang C, Liu T, Song J, Sun W, Wang G, Baxter B, Qureshi A, Liu X, Nogueira RG, Hu W. Endovascular treatment for acute basilar artery occlusion: A multicenter randomized controlled trial (ATTENTION). Int J Stroke. 2022 Aug;17(7):815-819. doi: 10.1177/17474930221077164. Epub 2022 Feb 22.

• Responsible Party: Wei Hu, Professor, The First Affiliated Hospital of University of Science and Technology of China
• ClinicalTrials.gov Identifier: NCT04751708
• Other Study ID Numbers: Attention
• First Posted: February 12, 2021
• Last Update Posted: June 14, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Wei Hu, The First Affiliated Hospital of University of Science and Technology of China:

thrombectomy; best medical management; endovascular treatment; randomized; mechanical thrombectomy

Additional relevant MeSH terms:

Stroke; Arterial Occlusive Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases