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

Not Applicable

Suspended

• Conditions: Vertebrobasilar Stroke
• Interventions: Procedure: Endovascular treatment; Other: Standard medical treatment

• Registration Number: NCT04743076
• Lead Sponsor: Xinqiao Hospital of Chongqing

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.

Study Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-08
• Study Start: 2021-03-16
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-14
• Primary Completion: 2024-05-16
• Study Completion: 2024-05-16

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 386

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Standard medical treatment	Standard medical treatment plus endovascular treatment
Control group	Standard medical treatment	Standard medical treatment alone
Intervention group	Endovascular treatment	Standard medical treatment plus endovascular treatment

Primary Outcome Measures

Name	Time	Method
Modified Rankin scale score	90 days	disability level

Secondary Outcome Measures

Name	Time	Method
Rate of a score of 0~2 on modified Rankin scale	90 days	Functional independence
Improvement in NIHSS between baseline and 24 hours	at 24 hours from randomization	neurological changes
Improvement in NIHSS between baseline and 5~7d	at 5~7 days from randomization	neurological changes
Improvement in GCS between baseline and 24 hours	at 5~7 days from randomization	neurological changes
Asymptomatic intracranial hemorrhage within 48 hours	within 48 hours after endovascular treatment	evaluate intracranial hemorrhage
Procedural-related complications and severe adverse events	within 90 days	evaluate complications and any adverse events
Serious non-hemorrhagic adverse events	within 90 days	evaluate complications and any adverse events
Score of 90-day EQ-5D scale	90 days	Functional independence
Mortality within 90 days	90 days	evaluate death rate of the two treatment groups
Symptomatic intracranial hemorrhage within 48 hours	within 48 hours after endovascular treatment	evaluate intracranial hemorrhage

Trial Locations

Locations (16)

Banan District People's Hospital; 🇨🇳 Banan, Chongqing, China

Xinqiao Hospital of Army Medical University; 🇨🇳 Chongqing, Chongqing, China

Jiangmen Central Hospital; 🇨🇳 Jiangmen, Guangdong, China

Wuyi Traditional Chinese Medicine Hospital; 🇨🇳 Jiangmen, Guangdong, China

Chinese Medical Hospital of Zhongshan; 🇨🇳 Zhongshan, Guangdong, China

Maoming Traditional Chinese Medicine Hospital; 🇨🇳 Maoming, Guangdong, China

Nanyang Central Hospital; 🇨🇳 Nanyang, Henan, China

The 904th Hospital of CPLA; 🇨🇳 Wuxi, Jiangsu, China

Wuhan No. 1 Hospital; 🇨🇳 Wuhan, Hubei, China

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Yijishan Hospital of Wannan Medical College; 🇨🇳 Wuhu, Anhui, China

The 924th Hospital of CPLA; 🇨🇳 Guilin, Guangxi, China

Danzhai People's Hospital; 🇨🇳 Danzhai, Guizhou, China

The First Affiliated Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

The Affiliated Hospital of Southwest Medical University; 🇨🇳 Luzhou, Sichuan, China

Xuzhou Central Hospital; 🇨🇳 Xuzhou, Jiangsu, China