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

Study Overview
=================
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.

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

Conditions
-----------------
Vertebrobasilar Stroke

Intervention / Treatment
-----------------
* Procedure: Endovascular treatment
* Other: Standard medical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: i. 18   80 years old, pc-ASPECTS score ≥ 6; ii. > 80 years old, pc-ASPECTS score ≥ 8 and mRS = 0 before the onset NIHSS score ≥ 10 before randomization; VA-V4 or basilar artery occlusion proved by CTA/MRA/DSA; Time from stroke onset to randomization within 23.5 hours; Written informed consent is obtained from patients and/or their legal representatives. Exclusion Criteria: CT or MR evidence of intracranial hemorrhage; Pre-morbidity with a modified Rankin scale score ≥ 3; The patient is in deep coma; Currently in pregnant or lactating or serum beta HCG test is positive on admission; Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel; Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys; Significant mass effect in the cerebellar hemisphere or hydrocephalus on imaging; Imaging manifestations of diffuse bilateral brainstem ischemia; Multivessel occlusive disease (combined with anterior and posterior circulation occlusion or subtotal occlusion); Cerebral vasculitis, intracranial arteriovenous malformation, aneurysm, or brain tumor with mass effect; Participating in other clinical trials; Any terminal illness with life expectancy less than 6 months; Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations; Past neurological or psychiatric diseases that hinder the assessment of neurological function; Unlikely to be available for 90-day follow-up.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Standard medical treatment plus endovascular treatment | Procedure: Endovascular treatment<br>* Endovascular treatment<br>Other: Standard medical treatment<br>* Standard medical treatment<br>|
| Active Comparator: Control group<br>Standard medical treatment alone | Other: Standard medical treatment<br>* Standard medical treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin scale score | disability level | 90 days | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endovascular treatment, thrombolysis