A Randomized Trial Of Endovascular Treatment For Acute Posterior Large Vessel Occlusion

NCT ID: NCT04743076

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 386 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2024-05-16

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.

Conditions

Vertebrobasilar Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

Standard medical treatment plus endovascular treatment

Group Type: EXPERIMENTAL

Endovascular treatment

Intervention Type: PROCEDURE

Endovascular treatment

Standard medical treatment

Intervention Type: OTHER

Standard medical treatment

Control group

Standard medical treatment alone

Group Type: ACTIVE_COMPARATOR

Standard medical treatment

Intervention Type: OTHER

Standard medical treatment

Interventions

Endovascular treatment

Endovascular treatment

Intervention Type: PROCEDURE

Standard medical treatment

Standard medical treatment

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role: lead

Responsible Party

Zhongming Qiu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qingwu Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology, Xinqiao Hospital of the Army Medical University

Wenjie Zi, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology, Xinqiao Hospital of the Army Medical University

Raul G Nogueira, MD

Role: PRINCIPAL_INVESTIGATOR

Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, USA

Jeffrey L Saver, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology, University of California, Los Angeles, USA

Locations

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, China

Banan District People's Hospital

Banan, Chongqing Municipality, China

Xinqiao Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

Wuyi Traditional Chinese Medicine Hospital

Jiangmen, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Maoming Traditional Chinese Medicine Hospital

Maoming, Guangdong, China

Chinese Medical Hospital of Zhongshan

Zhongshan, Guangdong, China

The 924th Hospital of CPLA

Guilin, Guangxi, China

Danzhai People's Hospital

Longquan, Guizhou, China

Nanyang Central Hospital

Nanyang, Henan, China

Wuhan No. 1 Hospital

Wuhan, Hubei, China

The 904th Hospital of CPLA

Wuxi, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

The First Affiliated Hospital of Jilin University

Changchun, Jilin, China

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 32080711 (View on PubMed)

Other Identifiers

BASILAR-2

Identifier Type: -

Identifier Source: org_study_id