Back to results

Endovascular Treatment for Acute Basilar Artery Occlusion

Primary Purpose

Basilar Artery Occlusion, Acute Cerebrovascular Accident, Stroke Due to Basilar Artery Occlusion

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

endovascular treatment

best medical management

About this trial

This is an interventional treatment trial for Basilar Artery Occlusion focused on measuring thrombectomy, best medical management, endovascular treatment, randomized, mechanical thrombectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Symptoms and signs compatible with ischemia in the basilar artery territory；
Basilar artery occlusion confirmed by CTA/MRA/DSA；
Age of 18 years or older；
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.
Written informed consent;
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

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

best medical management

endovascular treatment+ best medical management

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

a modified Rankin Score of 0-3

Favourable outcome at day 90 (± 14 days)

Secondary Outcome Measures

a modified Rankin Score of 0-2

Excellent outcome

Modified Rankin Score

The mRS is an ordinal hierarchical scale ranging from 0 to 5, with higher scores indicating more severe disability.

NIHSS score

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.

NIHSS score

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.

mortality

(Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%

symptomatic intracerebral hemorrhage (ICH)

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.

Full Information

NCT ID

NCT04751708

First Posted

February 9, 2021

Last Updated

September 14, 2022

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT04751708

Brief Title

Endovascular Treatment for Acute Basilar Artery Occlusion

Official Title

Endovascular Treatment for Acute Basilar Artery Occlusion - a Multicenter Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

February 21, 2021 (Actual)

Primary Completion Date

January 3, 2022 (Actual)

Study Completion Date

April 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Basilar Artery Occlusion, Acute Cerebrovascular Accident, Stroke Due to Basilar Artery Occlusion

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

340 (Actual)

8. Arms, Groups, and Interventions

Arm Title

best medical management

Arm Type

Active Comparator

Arm Description

Arm Title

endovascular treatment+ best medical management

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

endovascular treatment

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

best medical management

Intervention Description

best medical management

Primary Outcome Measure Information:

Title

a modified Rankin Score of 0-3

Description

Favourable outcome at day 90 (± 14 days)

Time Frame

90 (± 14 days) after procedure

Secondary Outcome Measure Information:

Title

a modified Rankin Score of 0-2

Description

Excellent outcome

Time Frame

90 (± 14 days) after procedure

Title

Modified Rankin Score

Description

The mRS is an ordinal hierarchical scale ranging from 0 to 5, with higher scores indicating more severe disability.

Time Frame

90 (± 14 days) after procedure

Title

NIHSS score

Description

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.

Time Frame

24 hours after procedure

Title

NIHSS score

Description

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.

Time Frame

5-7 days after procedure

Title

mortality

Description

(Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%

Time Frame

90 (± 14 days) after procedure

Title

symptomatic intracerebral hemorrhage (ICH)

Description

Time Frame

within 72 hours after procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Symptoms and signs compatible with ischemia in the basilar artery territory； Basilar artery occlusion confirmed by CTA/MRA/DSA； Age of 18 years or older； 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. Written informed consent; 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 CT/MR shows intracranial hemorrhage (patients with microbleeds on MR can be included if lesion diameter ≤5mm); CTA/MRA/DSA shows the artery is seriously tortuous, variability or dissection, and thrombectomy device cannot reach the target vessel; PC-ASPECTS on CT/CTA-Source Images/MRI-DWI <6 for patients<80 years (<8 for patients ≥80 years); CT or MR shows the cerebellar infarction with obvious space occupying effect and obvious compression of the fourth ventricle; Complete bilateral thalami or bilateral brainstem infarction confirmed by CT/MR; Occlusion of both anterior and posterior circulation confirmed by CTA/MRA/DSA; Intracranial tumors (except small meningiomas).

Facility Information:

Facility Name

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

City

Hefei

State/Province

Anhui

ZIP/Postal Code

239300

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

36239644

Citation

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.

Results Reference

derived

PubMed Identifier

35858168

Citation

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. No abstract available.

Results Reference

derived

PubMed Identifier

35102797

Citation

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.

Results Reference

derived

Learn more about this trial

Endovascular Treatment for Acute Basilar Artery Occlusion

We'll reach out to this number within 24 hrs