Clinical trial NCT04743076: A Randomized Trial Of Endovascular Treatment For Acute Posterior Large Vessel Occlusion
Official title: Standard Medical Treatment Plus Endovascular Treatment Versus Standard Medical Treatment Alone for Stroke Patient With Large Vessel Occlusion In The Posterior Circulation: A Multicenter, Randomized, Clinical Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Vertebrobasilar Stroke
Keywords: endovascular treatment
thrombolysis
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to investigate whether endovascular treatment can improve the 90-day functional outcome of acute large vessel occlusion in the posterior circulation.

Detailed description: At least seven randomized controlled trials have consistently shown that endovascular treatment can improve the functional outcome of stroke patients with acute anterior large vessel occlusion. However, these trials did not include patients with large vessel occlusion in the posterior circulation.

The hypothesis of this trial: Compared with standard medical treatment alone, standard medical treatment combined with endovascular treatment can significantly improve the 90-day functional outcome of acute large vessel occlusion in the posterior circulation.

Eligibility criteria: Inclusion Criteria:

1. Age: i. 18 \~ 80 years old, pc-ASPECTS score ≥ 6; ii. \> 80 years old, pc-ASPECTS score ≥ 8 and mRS = 0 before the onset
2. NIHSS score ≥ 10 before randomization;
3. VA-V4 or basilar artery occlusion proved by CTA/MRA/DSA;
4. Time from stroke onset to randomization within 23.5 hours;
5. Written informed consent is obtained from patients and/or their legal representatives.

Exclusion Criteria:

1. CT or MR evidence of intracranial hemorrhage;
2. Pre-morbidity with a modified Rankin scale score ≥ 3;
3. The patient is in deep coma;
4. Currently in pregnant or lactating or serum beta HCG test is positive on admission;
5. Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
6. Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys;
7. Significant mass effect in the cerebellar hemisphere or hydrocephalus on imaging;
8. Imaging manifestations of diffuse bilateral brainstem ischemia;
9. Multivessel occlusive disease (combined with anterior and posterior circulation occlusion or subtotal occlusion);
10. Cerebral vasculitis, intracranial arteriovenous malformation, aneurysm, or brain tumor with mass effect;
11. Participating in other clinical trials;
12. Any terminal illness with life expectancy less than 6 months;
13. Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
14. Past neurological or psychiatric diseases that hinder the assessment of neurological function;
15. Unlikely to be available for 90-day follow-up.

Primary outcomes:
measure: Modified Rankin scale score
timeFrame: 90 days
Secondary outcomes:
measure: Rate of a score of 0~2 on modified Rankin scale
timeFrame: 90 days
measure: Improvement in NIHSS between baseline and 24 hours
timeFrame: at 24 hours from randomization
measure: Improvement in NIHSS between baseline and 5~7d
timeFrame: at 5~7 days from randomization
measure: Improvement in GCS between baseline and 24 hours
timeFrame: at 24 hours from randomization
measure: Improvement in GCS between baseline and 24 hours
timeFrame: at 5~7 days from randomization
measure: Asymptomatic intracranial hemorrhage within 48 hours
timeFrame: within 48 hours after endovascular treatment
measure: Procedural-related complications and severe adverse events
timeFrame: within 90 days
measure: Serious non-hemorrhagic adverse events
timeFrame: within 90 days
measure: Score of 90-day EQ-5D scale
timeFrame: 90 days
measure: Mortality within 90 days
timeFrame: 90 days
measure: Symptomatic intracranial hemorrhage within 48 hours
timeFrame: within 48 hours after endovascular treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Wuhu
country: China
facility: Yijishan Hospital of Wannan Medical College
state: Anhui
city: Banan
country: China
facility: Banan District People's Hospital
state: Chongqing
city: Chongqing
country: China
facility: Xinqiao Hospital of Army Medical University
state: Chongqing
city: Jiangmen
country: China
facility: Wuyi Traditional Chinese Medicine Hospital
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Maoming
country: China
facility: Maoming Traditional Chinese Medicine Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Chinese Medical Hospital of Zhongshan
state: Guangdong
city: Guilin
country: China
facility: The 924th Hospital of CPLA
state: Guangxi
city: Danzhai
country: China
facility: Danzhai People's Hospital
state: Guizhou
city: Nanyang
country: China
facility: Nanyang Central Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan No. 1 Hospital
state: Hubei
city: Wuxi
country: China
facility: The 904th Hospital of CPLA
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Affiliated Hospital of Jilin University
state: Jilin
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
Study officials:
affiliation: Neurology, Xinqiao Hospital of the Army Medical University
name: Qingwu Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology, Xinqiao Hospital of the Army Medical University
name: Wenjie Zi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, USA
name: Raul G Nogueira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology, University of California, Los Angeles, USA
name: Jeffrey L Saver, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Writing Group for the BASILAR Group; Zi W, Qiu Z, Wu D, Li F, Liu H, Liu W, Huang W, Shi Z, Bai Y, Liu Z, Wang L, Yang S, Pu J, Wen C, Wang S, Zhu Q, Chen W, Yin C, Lin M, Qi L, Zhong Y, Wang Z, Wu W, Chen H, Yao X, Xiong F, Zeng G, Zhou Z, Wu Z, Wan Y, Peng H, Li B, Hu X, Wen H, Zhong W, Wang L, Jin P, Guo F, Han J, Fu X, Ai Z, Tian X, Feng X, Sun B, Huang Z, Li W, Zhou P, Tu M, Sun X, Li H, He W, Qiu T, Yuan Z, Yue C, Yang J, Luo W, Gong Z, Shuai J, Nogueira RG, Yang Q. Assessment of Endovascular Treatment for Acute Basilar Artery Occlusion via a Nationwide Prospective Registry. JAMA Neurol. 2020 May 1;77(5):561-573. doi: 10.1001/jamaneurol.2020.0156.