Safety and Efficacy of Endovascular Treatment for Progressive Stroke Due to Vertebrobasilar Artery Occlusion: A Multicenter, Prospective, Open-Label Randomized Controlled Trial With Blinded Endpoint Assessment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The proportion of patients achieving modified Rankin Scale (mRS) score 0-3 at 90 days
研究概览
简要总结
This multicenter, prospective, open-label randomized controlled trial with blinded assessment was designed to assess the efficacy and safety of endovascular treatment for progressive stroke due to vertebrobasilar artery occlusion.
详细描述
This multicenter, prospective, open-label, randomized controlled trial with blinded endpoint assessment (PROBE design) was designed to evaluate endovascular treatment (EVT) in patients with progressive stroke due to vertebrobasilar artery occlusion (VBAO). Progressive stroke due to VBAO was defined as vertebrobasilar artery occlusion confirmed by CTA, MRA, or DSA, accompanied by neurological deterioration occurring between 24 hours and 14 days after symptom onset, defined as an increase of ≥4 points in the National Institutes of Health Stroke Scale (NIHSS) score resulting in a total NIHSS score ≥10 in patients with an initial NIHSS score <10. Participants will be randomly assigned in a 1:1 ratio to receive EVT plus medical therapy or medical therapy alone. The primary endpoint is the proportion of patients with good functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 0 to 3. Secondary outcomes include the distribution of mRS scores at 90 days, all-cause mortality at 90 days, and the incidence of symptomatic intracranial hemorrhage (sICH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Acute ischemic stroke, with a National Institutes of Health Stroke Scale (NIHSS) score of <10 at initial symptom onset, and no prior endovascular treatment.
- •Stroke progression occurring from 24 hours to 14 days after initial symptom onset, defined as an NIHSS score of ≥10 with an increase of ≥4 points from baseline.
- •Acute basilar artery occlusion or dominant vertebral artery occlusion with contralateral occlusion or hypoplasia, confirmed by CTA, MRA or DSA.
- •Posterior circulation Alberta Stroke Program Early CT Score (pc-ASPECTS) of ≥6 and Pons-Midbrain Index (PMI) of ≤3 on CT or diffusion-weighted imaging (DWI).
- •Randomization within 24 hours of stroke progression.
- •Pre-stroke mRS score of 0-
- •Provision of signed informed consent by the patient or their legal representative.
排除标准
- •Any sign of intracranial hemorrhage (except microbleeds) on baseline brain imaging.
- •Imaging confirms the progression of symptoms caused by intracranial hemorrhage, brain edema, or other clear causes.
- •Extensive cerebellar infarction with significant mass effect or bilateral thalamic infarction on baseline neuroimaging.
- •Presence of untreated intracranial aneurysm, intracranial tumor (except small meningioma and aneurysms <3 mm in diameter), or intracranial arteriovenous malformation.
- •Known or highly suspected chronic responsible artery occlusion.
- •Presence of severe stenosis in the extracranial or intracranial segment of the responsible artery, arterial dissection, or excessive vascular tortuosity that may prevent successful delivery or navigation of endovascular devices.
- •Known contraindication to contrast medium (except mild rash).
- •Refractory hypertension not controlled by medication, defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg.
- •Known pregnancy or lactation, or a positive pregnancy test prior to randomization.
- •Known dementia or psychiatric disease precluding completion of neurological assessment and follow-up.
- •Life expectancy <1 year, including patients with malignancy or advanced cardiopulmonary disease.
- •Current participation in any other clinical trial of drugs or medical devices, or anticipated participation in another such trial within 3 months after enrollment.
- •Acute ischemic stroke within 48 hours after cardiovascular or cerebrovascular interventional treatment or major surgery; patients presenting >48 hours after such procedures were eligible.
- •Recent (within 1 month) gastrointestinal or genitourinary bleeding, acute myocardial infarction, or traumatic brain injury.
- •Multivessel severe stenosis or occlusion confirmed by CTA, MRA, or DSA.
- •Known or suspected central nervous system vasculitis.
- •Known hereditary or acquired bleeding diathesis, coagulation factor deficiency, current use of oral anticoagulants with an INR >1.5, or active bleeding.
- •Blood glucose <2.8 or >22.2 mmol/L; platelet count <100 × 10⁹/L; estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² or serum creatinine ≥177 μmol/L (2.0 mg/dL).
- •Any other condition deemed by the site investigator to make the patient unsuitable for participation.
研究组 & 干预措施
Endovascular Treatment Group
Participants randomized to the endovascular recanalization arm will receive endovascular treatment in addition to medical therapy. The procedure aims to achieve recanalization of the occluded vertebrobasilar artery 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 neurointerventionalists.
干预措施: Endovascular Recanalization (Procedure)
Medical Therapy Alone Group
Participants randomized to this arm will receive medical therapy alone, consistent with current guideline recommendations for the acute and secondary prevention phases of ischemic stroke. No endovascular recanalization procedures are permitted after randomization.
干预措施: Medical Therapy Alone (Drug)
结局指标
主要结局
The proportion of patients achieving modified Rankin Scale (mRS) score 0-3 at 90 days
时间窗: 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.
次要结局
- Ordinal shift analysis of mRS score at 90 days after randomization(90±14 days after randomization)
- The proportion of patients achieving mRS scores 0-1 and 0-2 at 90 days(90±14 days after randomization)
- The National Institutes of Health Stroke Scale (NIHSS) score at 24 hours(24 (-6/+12) hours after randomization)
- The NIHSS score at 7 days after randomization or discharge (whichever came first), as well as changes from baseline(7 days after randomization or at discharge)
- The score on the European Quality of life 5-Dimension 5-Level (EQ-5D-5L) patient-reported questionnaire score at 90 days(90±14 days after randomization)
- The proportion of Barthel index 95-100 points at 90 days(90±14 days after randomization)
- The recanalization of the vertebrobasilar artery at 24 hours after randomization (confirmed by CTA, MRA, DSA, or TCD)(24 (-6/+12) hours after randomization)
- The rate of technical success is defined as the successful recanalization of the target vessel at the end of the procedure (expanded Thrombolysis in Cerebral Infarction scale [eTICI] 2b-3)(At the end of the procedure)
研究者
Feng Gao
Vice-Director of Interventional Neuroradiology, Department of Neurology
Beijing Tiantan Hospital