STRAIT: Evaluation of Safety and Performance of the BOBBY™ Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 171
- 试验地点
- 9
- 主要终点
- The primary endpoint is the proportion of patients with successful reperfusion defined as mTICI≥2b per Core Laboratory evaluation.
研究概览
简要总结
Evaluation of the safety and performance of the BOBBY™ Balloon Guide Catheter (BGC) in patients with an acute ischemic stroke treatment, a sudden reduction or termination of the blood circulation of the brain, caused by a clot. Immediate treatment is needed to restore the blood circulation in the brain, performing a mechanical removal of the clot (thrombectomy). To prevent clot particles migrating in other parts of the brain circulation during the thrombectomy, balloon guiding catheters are inserted. The aim of the study is to evaluate the safety and performance of the balloon guide catheter BOBBY™ by collecting information from patients, treated with a mechanical thrombectomy and the balloon guide catheter (BOBBY™) after acute ischemic stroke
详细描述
The main objective of the STRAIT study is to assess the performance of the mechanical thrombectomy using a BOBBY™ Balloon Guide Catheter (BGC) as adjunctive device for endovascular treatment of patients suffering from an anterior circulation acute ischemic stroke. Interventional procedures and clinical follow-up will be performed per standard of care. Patient health-related and imaging data will be collected as of stroke onset time up to 90 days follow up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 18 and ≤ 85 years of age
- •Informed consent by the patient or legal authorized representative for data collection is obtained
- •Patient eligible for the mechanical thrombectomy treatment with adjunctive use of the BOBBY™ BGC
- •Patient presenting with an anterior circulation large-vessel occlusion of distal internal carotic artery (ICA ) through proximal M2 confirmed by computed tomograph angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).
- •Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 based on baseline CT or MR imaging
- •Treatment initiated (groin puncture) within 8 hours of symptom onset.
- •Patient with a pre-treatment National Institutes of Health Stroke Scale (NIHSS) score ≥5
- •Patient with no personal condition disabling the site to contact him/her at 90 days after procedure
排除标准
- •Patient has evidence of cerebral ischemia in the posterior circulation
- •Patient presents severe unilateral or bilateral carotid artery stenosis requiring stent treatment during the procedure
- •Pregnancy or breastfeeding
- •Patient presents other serious medical illness (e.g., cancer) with estimated life expectancy of less than 3 months
- •Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation
- •Patient is already participating in an investigational drug or device trial (change routine care of the patient)
- •Patient has evidence of intracerebral hemorrhage on initial imaging
- •Patient has a significant mass effect with midline shift
结局指标
主要结局
The primary endpoint is the proportion of patients with successful reperfusion defined as mTICI≥2b per Core Laboratory evaluation.
时间窗: 90 days
Successful reperfusion defined as mTICI≥2b by independent Core Laboratory evaluation.
次要结局
- Near complete reperfusion defined as mTICI≥2c(90 days)
- Patients with modified First Pass Effect observed (mFPE: mTICI≥2b after one pass)(90 days)
- Mortality at 24 hours and 90 days(24 hours and 90 days)
- Safety evaluation device malfunction(90 days)
- Occurence of new territory embolization(24 hours)
- Technical success: successful placement of the BOBBY™ BGC at the skull base(90 days)
- 90 days post-procedure modified Ranking Scale (mRS)(90 days)
- NIHSS at 24h post-procedure(24 hours)
- Procedure related events(24 hours)
- Occurrence of symptomatic intracranial hemorrhage (sICH) within 24 hours(24 hours)