Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment
NCT ID: NCT02441556
Last Updated: 2018-07-31
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
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COMPLETED
NA
131 participants
INTERVENTIONAL
2015-01-31
2017-12-30
Brief Summary
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Detailed Description
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In this trial, the investigators did not have age or NIHSS score limit, patients who did not fulfill the requirements for IV rt-PA can also be included into the trial, the investigators also extended the time window to 8 hours which will accelerate the recruitment of potential subjects. In endovascular treatment arm, the time interval between randomization to procedure finish will be controlled within 120 mins. The preparation of endovascular treatment will start immediately after randomization for those eligible patients for IV rt-PA within 4.5 hours after acute stroke onset, with no need to wait for the one-hour rt-PA infusion. A positive trial will suggest substantial clinical benefit from endovascular treatment plus standard medical therapy over standard medical therapy. This trial may provide novel evidence of adopting endovascular treatment for acute patients with BA occlusion, which may consequently advance our current approach for acute stroke treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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standard medical therapy
Patients receive standard medical therapy alone.
standard medical therapy
If the patient meets the criteria for IV rt-PA within 4.5 h of stroke onset, he/she will receive a single alteplase dose of 0.9 mg/kg IV(maximum dose: 90mg), with 10% given as a bolus, followed by continuous IV infusion of the other dose within 1h. All patients will receive standard medical therapy. The standard medical therapy conforms with the current American Heart Association/American Stroke Association guidelines.
endovascular + standard medical therapy
Patients receive endovascular treatment plus standard medical therapy.
endovascular treatment
The endovascular treatment is comprised of thrombolysis, mechanical thrombectomy, stenting, or a combination of all these approaches. Generally, Solitaire FR is preferred, other devices such as Trevo or future advanced devices can also be considered which will be decided by the executive committee.
standard medical therapy
If the patient meets the criteria for IV rt-PA within 4.5 h of stroke onset, he/she will receive a single alteplase dose of 0.9 mg/kg IV(maximum dose: 90mg), with 10% given as a bolus, followed by continuous IV infusion of the other dose within 1h. All patients will receive standard medical therapy. The standard medical therapy conforms with the current American Heart Association/American Stroke Association guidelines.
Interventions
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endovascular treatment
The endovascular treatment is comprised of thrombolysis, mechanical thrombectomy, stenting, or a combination of all these approaches. Generally, Solitaire FR is preferred, other devices such as Trevo or future advanced devices can also be considered which will be decided by the executive committee.
standard medical therapy
If the patient meets the criteria for IV rt-PA within 4.5 h of stroke onset, he/she will receive a single alteplase dose of 0.9 mg/kg IV(maximum dose: 90mg), with 10% given as a bolus, followed by continuous IV infusion of the other dose within 1h. All patients will receive standard medical therapy. The standard medical therapy conforms with the current American Heart Association/American Stroke Association guidelines.
Eligibility Criteria
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Inclusion Criteria
2. Acute ischemic stroke consistent with infarction in the basilar artery territory;
3. Basilar artery occlusion confirmed by CTA/MRA/DSA, within 8 hours of estimated occlusion time;
4. Written informed consent from patient or surrogate, if unable to provide consent.
Exclusion Criteria
2. Premorbid mRS ≥ 3 points;
3. Currently in pregnant or lactating;
4. Known serious sensitivity to radiographic contrast agents and nitinol metal;
5. Current participation in another investigation drug or device study;
6. Uncontrolled hypertension defined as systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg that cannot be controlled except with continuous parenteral antihypertensive medication;
7. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or oral anticoagulant therapy with INR \>1.7 or institutionally equivalent prothrombin time;
8. Baseline lab values: glucose \< 50 mg/dl or \> 400 mg/dl, platelets \<100\*109/L, or Hct\<25%;
9. Arterial tortuosity that would prevent the device from reaching the target vessel;
10. Life expectancy less than 1 year;
11. History of major hemorrhage in the past 6 months;
12. Angiographic evidence of significant cerebellar mass effect or acute hydrocephalus.
13. Angiographic evidence of bilateral extended brainstem ischemia.
18 Years
ALL
No
Sponsors
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Xinfeng Liu
OTHER
Responsible Party
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Xinfeng Liu
Professor and Chairman of Department of Neurology
Principal Investigators
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Xinfeng Liu, Doctor
Role: STUDY_CHAIR
Departmnet of Neurology, Jinling Hospital
Locations
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123rd Hospital of The People's Liberation Army
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
the First Affiliated Hospital of An'hui Medical University
Hefei, Anhui, China
the First People's Hospital of Huainan
Huainan, Anhui, China
Lu'an Affiliated Hospital of Anhui Medical University
Lu'an, Anhui, China
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, China
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
Fuzhou General Hospital of Nanjing Military Region
Fuzhou, Fujian, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
175th hospital of PLA, the Affiliated Southeast Hospital of Xiamen University
Xiamen, Fujian, China
Affiliated Zhongshan Hospital of Xiamen University
Xiamen, Fujian, China
Guangdong No.2 Provincial People's Hospital
Guangzhou, Guangdong, China
The Chinese Armed Police Force Guangdong Armed Police Corps hospital
Guangzhou, Guangdong, China
Maoming People's Hospital
Maoming, Guangdong, China
Shenzhen Nanshan Hospital
Shenzhen, Guangdong, China
Henan Provincial People's Hospital,Zhengzhou University
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Hubei Zhongshan Hospital
Wuhan, Hubei, China
Wuhan No.1 Hospital
Wuhan, Hubei, China
Changsha Central Hospital
Changsha, Hunan, China
Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
101st hospital of PLA
Wuxi, Jiangsu, China
the Second Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
the Third People's Hospital of Yancheng
Yancheng, Jiangsu, China
Yangzhou No.1 People's Hospital
Yangzhou, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
the First People's Hospital of Yangzhou， Yangzhou University
Yangzhou, Jiangsu, China
Yangzhou Hongquan Hospital
Yangzhou, Jiangsu, China
Linyi People's Hospital
Linyi, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
Taian City Central Hospital
Taian, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Chengdu Military General Hospital
Chengdu, Sichuan, China
Sichuan People's Hospital
Chengdu, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
the First People's Hospital of Hangzhou,Nanjing Medical University
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Lishui Central Hospital
Lishui, Zhejiang, China
Xinqiao Hospital, the Third Military Medical University
Chongqing, , China
Countries
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References
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Other Identifiers
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JLH-NEURO-2015-001
Identifier Type: -
Identifier Source: org_study_id
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