The Efficacy and Safety of Endovascular Therapy for Acute... | NCT07333950

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endovascular Treatment Group	Experimental	Participants randomized to the endovascular recanalization arm will receive endovascular treatment in addition to best medical management. The procedure aims to achieve recanalization of the occluded posterior circulation vessel using mechanical thrombectomy techniques, including stent retriever and/or aspiration-based approaches. When necessary, adjunctive endovascular measures may be performed as rescue therapy at the discretion of the treating neurointerventionalist.	Procedure: Endovascular Recanalization Strategy
Best Medical Management Group	Other	Participants randomized to this arm will receive best medical management alone, consistent with current guideline recommendations for the acute and secondary prevention phases of ischemic stroke. No endovascular recanalization procedures are permitted after randomization.	Drug: Best Medical Management

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endovascular Recanalization Strategy	Procedure	The endovascular approach is selected by the treating neurointerventionalist based on angiographic findings, occlusion characteristics, and procedural feasibility. Permitted techniques include mechanical thrombectomy using stent retriever and/or aspiration-based methods. Adjunctive endovascular procedures, such as balloon angioplasty, stent placement, or intra-arterial thrombolysis, may be used when deemed necessary to achieve or maintain vessel patency. Angiographic reperfusion is assessed during the procedure, and treatment is terminated once adequate revascularization is obtained. Subsequent medical management is individualized according to stroke mechanism, procedural findings, and post-treatment imaging.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of modified Rankin scale 0-3 at 90 (±14) days after randomization	The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.	90±14 days after randomization

Secondary Outcomes

Measure	Description	Time Frame
MRS score as an ordinal scale at 90 (±14) days after randomization	The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.	90±14 days after randomization

Other Outcomes

Measure	Description	Time Frame
Rate of any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification within 18-36 hours of randomization	Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below: 4 points total NIHSS at the time of diagnosis compared to immediately before worsening. 2 point in one NIHSS category. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention. Absence of alternative explanation for deterioration.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The age ranged from 18 to 80 years
Acute ischemic stroke in posterior circulation, the time from stroke onset (or finally found normal) to randomization was within 24 hours
Acute basilar artery occlusion confirmed by CTA,MRA,or DSA
Posterior circulation large core infarction:NCCT or DWI showed pc-ASPECTS≤5, or Pons-Midbrain Index (PMI)≥3
NIHSS score ≥10 before randomization
Pre-stroke mRS of 0-2
Each patient or their legal representative must provide written informed consent before enrolment

Exclusion Criteria:

Any sign of intracranial hemorrhage (except microbleeds) on brain imaging prior to randomization
Complete cerebellar infarct with significant mass effect, or bilateral thalamic infarction as evidenced by baseline neuroimaging
Known or highly suspected chronic occlusion of basilar artery
History of contraindication for contrast medium (except mild rash)
Current pregnant or breast-feeding
Refractory hypertension (defined as systolic blood pressure>220 mmHg or diastolic blood pressure>110 mmHg) that cannot be controlled by drug treatment;
Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up
It is known that patients with dementia or mental illness cannot complete neurological function assessment and follow-up
Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.)
Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months
Any other condition (in the opinion of the site investigator) that inappropriate to participate this study
CTA/MRA/DSA confirmed occlusion of anterior and posterior circulation
Central nervous system vasculitis has been diagnosed or clinically suspected
Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR>1.7
Blood glucose<2.7 or>22.2 mmol/L; Platelet count<50×109/L, glomerular filtration rate<30ml/min or serum creatinine ≥ 3 mg/dl
Acute cerebral infarction occurred within 48 hours after cardio cerebral vascular intervention or major surgery (patients over 48 hours can be included in the group)

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases