Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment

NCT02441556 | Completed DMC

• 1 other identifier: JLH-NEURO-2015-001
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 44

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.

Conditions

Stroke Due to Basilar Artery Occlusion; Acute Cerebrovascular Accidents

Keywords

thrombectomy; rt-PA; stroke; endovascular treatment; randomized

Outcome Measures

Primary Outcomes (1)

• modified Rankin Scale (mRS)

  A score of 0-3 will be considered as the favorable outcome.

  at 90 days from randomization

Secondary Outcomes (17)

• 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

• PC-ASPECT score on CT/MRI

  at 24 hours from randomization

• GCS score

  at 24 hours from randomization

Study Arms (2)

standard medical therapy

ACTIVE COMPARATOR

Patients receive standard medical therapy alone.

Other: standard medical therapy

endovascular + standard medical therapy

EXPERIMENTAL

Patients receive endovascular treatment plus standard medical therapy.

Device: endovascular treatment; Other: standard medical therapy

Interventions

endovascular treatment DEVICE

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.

endovascular + standard medical therapy

standard medical therapy OTHER

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; standard medical therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinfeng Liu: lead

Study Sites (44)

123rd Hospital of The People's Liberation Army

Bengbu, Anhui, 233010, China

Location

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

the First Affiliated Hospital of An'hui Medical University

Hefei, Anhui, China

Location

the First People's Hospital of Huainan

Huainan, Anhui, China

Location

Lu'an Affiliated Hospital of Anhui Medical University

Lu'an, Anhui, 237005, China

Location

Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, 241001, China

Location

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Fuzhou General Hospital of Nanjing Military Region

Fuzhou, Fujian, 350025, China

Location

Zhongshan Hospital Xiamen University

Xiamen, Fujian, 361004, China

Location

175th hospital of PLA, the Affiliated Southeast Hospital of Xiamen University

Xiamen, Fujian, China

Location

Affiliated Zhongshan Hospital of Xiamen University

Xiamen, Fujian, China

Location

Guangdong No.2 Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

The Chinese Armed Police Force Guangdong Armed Police Corps hospital

Guangzhou, Guangdong, 510507, China

Location

Maoming People's Hospital

Maoming, Guangdong, China

Location

Shenzhen Nanshan Hospital

Shenzhen, Guangdong, China

Location

Henan Provincial People's Hospital,Zhengzhou University

Zhengzhou, Henan, 450003, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Hubei Zhongshan Hospital

Wuhan, Hubei, China

Location

Wuhan No.1 Hospital

Wuhan, Hubei, China

Location

Changsha Central Hospital

Changsha, Hunan, China

Location

Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210002, China

Location

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

101st hospital of PLA

Wuxi, Jiangsu, China

Location

the Second Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Location

the Third People's Hospital of Yancheng

Yancheng, Jiangsu, China

Location

Yangzhou No.1 People's Hospital

Yangzhou, Jiangsu, 225012, China

Location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Location

the First People's Hospital of Yangzhou， Yangzhou University

Yangzhou, Jiangsu, China

Location

Yangzhou Hongquan Hospital

Yangzhou, Jiangsu, China

Location

Linyi People's Hospital

Linyi, Shandong, 276002, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266005, China

Location

Qingdao Municipal Hospital

Qingdao, Shandong, China

Location

Taian City Central Hospital

Taian, Shandong, 271099, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, 264099, China

Location

Chengdu Military General Hospital

Chengdu, Sichuan, China

Location

Sichuan People's Hospital

Chengdu, Sichuan, China

Location

Mianyang Central Hospital

Mianyang, Sichuan, China

Location

the First People's Hospital of Hangzhou,Nanjing Medical University

Hangzhou, Zhejiang, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

Lishui Central Hospital

Lishui, Zhejiang, China

Location

Xinqiao Hospital, the Third Military Medical University

Chongqing, China

Location

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xinfeng Liu, Doctor

  Departmnet of Neurology, Jinling Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chairman of Department of Neurology

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: May 12, 2015
• Study Start: January 1, 2015
• Primary Completion: September 27, 2017
• Study Completion: December 30, 2017
• Last Updated: July 31, 2018

Record last verified: 2016-12

Locations

CN (44)