Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment
- Conditions
- Stroke Due to Basilar Artery OcclusionAcute Cerebrovascular Accidents
- Interventions
- Device: endovascular treatmentOther: standard medical therapy
- Registration Number
- NCT02441556
- Lead Sponsor
- Xinfeng Liu
- Brief Summary
This trial will provide valuable insights into the safety and efficacy of endovascular treatment for acute ischemic stroke patients with basilar artery occlusion within 8 hours of estimated occlusion time.
- Detailed Description
This clinical trial is designed to compare the safety and efficacy of endovascular treatment plus standard medical therapy with standard medical therapy alone for acute BA occlusion presented within 8 h of estimated occlusion time. There is only one ongoing clinical trial-Basilar Artery International Cooperation Study (BASICS) (NCT01717755) aimed to evaluate the efficacy and safety of additional intra-arterial treatment after intravenous treatment in 750 patients with BA occlusion, which was anticipated to be completed in Oct 2017. Initiation of intra-arterial therapy should be feasible within 6 hours of estimated time of BA occlusion. And patients are required to have an NIHSS ≥ 10 at time of randomization, and take IV rt-PA, age between 18-85 years old.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
- Age ≥18 years;
- Acute ischemic stroke consistent with infarction in the basilar artery territory;
- Basilar artery occlusion confirmed by CTA/MRA/DSA, within 8 hours of estimated occlusion time;
- Written informed consent from patient or surrogate, if unable to provide consent.
- Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of Cerebral hemorrhage on presentation;
- Premorbid mRS ≥ 3 points;
- Currently in pregnant or lactating;
- Known serious sensitivity to radiographic contrast agents and nitinol metal;
- Current participation in another investigation drug or device study;
- 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;
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or oral anticoagulant therapy with INR >1.7 or institutionally equivalent prothrombin time;
- Baseline lab values: glucose < 50 mg/dl or > 400 mg/dl, platelets <100*109/L, or Hct<25%;
- Arterial tortuosity that would prevent the device from reaching the target vessel;
- Life expectancy less than 1 year;
- History of major hemorrhage in the past 6 months;
- Angiographic evidence of significant cerebellar mass effect or acute hydrocephalus.
- Angiographic evidence of bilateral extended brainstem ischemia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description endovascular + standard medical therapy standard medical therapy Patients receive endovascular treatment plus standard medical therapy. standard medical therapy standard medical therapy Patients receive standard medical therapy alone. endovascular + standard medical therapy endovascular treatment Patients receive endovascular treatment plus standard medical therapy.
- Primary Outcome Measures
Name Time Method modified Rankin Scale (mRS) at 90 days from randomization A score of 0-3 will be considered as the favorable outcome.
- Secondary Outcome Measures
Name Time Method PC-ASPECT score on CT/MRI at 24 hours from randomization NIHSS score at 5-7 days from randomization mortality at 3 months from randomization mRS score 0-2 at 90 days from randomization Change of mRS score(shift analysis) at 90 days from randomization Vessel recanalization rate evaluated by CT angiography or MRA at 24 hours from randomization GCS score at 5-7 days from randomization EuroQol 5D (EQ-5D) at 90 days from randomization symptomatic intracerebral hemorrhage (ICH) within 24 hours from randomization incidence of nonbleeding severe adverse events (SAEs) within 90 days from randomization severity of nonbleeding severe adverse events (SAEs) within 90 days from randomization incidence of procedure and device related complications within 90 days from randomization i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.
incidence of non-intracerebral hemorrhage complications at 90 days from randomization severity of non-intracerebral hemorrhage complications within 90 days from randomization severity of procedure and device related complications within 90 days from randomization i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.
Trial Locations
- Locations (44)
123rd Hospital of The People's Liberation Army
🇨🇳Bengbu, Anhui, China
Yijishan Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Fuzhou General Hospital of Nanjing Military Region
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Zhongshan Hospital Xiamen University
🇨🇳Xiamen, Fujian, China
Shenzhen Nanshan Hospital
🇨🇳Shenzhen, Guangdong, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Lishui Central Hospital
🇨🇳Lishui, Zhejiang, 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
Guangdong No.2 Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
The Chinese Armed Police Force Guangdong Armed Police Corps hospital
🇨🇳Guangzhou, Guangdong, China
Daping Hospital, Third Military Medical University
🇨🇳Chongqing, Chongqing, China
Affiliated Zhongshan Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Maoming People's Hospital
🇨🇳Maoming, Guangdong, China
Henan Provincial People's Hospital,Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Changsha Central Hospital
🇨🇳Changsha, Hunan, China
Wuhan No.1 Hospital
🇨🇳Wuhan, Hubei, China
Jinling Hospital, Medical School of Nanjing University
🇨🇳Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
101st hospital of PLA
🇨🇳Wuxi, Jiangsu, China
Nanjing First Hospital, Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
the Third People's Hospital of Yancheng
🇨🇳Yancheng, 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
the First People's Hospital of Hangzhou,Nanjing Medical University
🇨🇳Hangzhou, Zhejiang, China
Qingdao Municipal Hospital
🇨🇳Qingdao, Shandong, China
Taian City Central Hospital
🇨🇳Taian, Shandong, China
175th hospital of PLA, the Affiliated Southeast Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
the Second Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Yangzhou No.1 People's Hospital
🇨🇳Yangzhou, Jiangsu, China
Linyi People's Hospital
🇨🇳Linyi, Shandong, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, 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
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Xinqiao Hospital, the Third Military Medical University
🇨🇳Chongqing, China
Hubei Zhongshan Hospital
🇨🇳Wuhan, Hubei, China