A Randomized Trial Of Endovascular Treatment For Acute Posterior Large Vessel Occlusion (BASILAR-2)

Army Medical University of People's Liberation Army

Status: Suspended

Conditions: Vertebrobasilar Stroke

Treatments: Other: Standard medical treatment; Procedure: Endovascular treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04743076

BASILAR-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 386 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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386 participants in 2 patient groups

Intervention group

Experimental group

Description:

Standard medical treatment plus endovascular treatment

Treatment:

Other: Standard medical treatment

Procedure: Endovascular treatment

Control group

Active Comparator group

Description:

Standard medical treatment alone

Treatment:

Other: Standard medical treatment