The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 86
- 主要终点
- Utility-weighted 90-day Modified Rankin Score
研究概览
简要总结
The primary objective of the trial is to establish the effectiveness of IAT (versus medical management) in patients with moderate-large infarcts (NCCT ASPECTS 2-5) at baseline, with adaptive enrichment to better define the upper limit of infarct volume for treatment eligibility. Furthermore, the investigators aim to determine whether certain subgroups of patients with large baseline infarcts will have a greater treatment benefit. Finally, the investigators will assess the agreement of ASPECTS scores between site investigators, the core imaging lab, and automated software.
详细描述
Prospective, randomized, open-label, blinded endpoint study. Patients presenting with symptoms of AIS who have evidence of a moderate-large infarct volume (Non-contrast CT Alberta Stroke Program Early CT score [NCCT ASPECTS] 2-5 in the anterior circulation will be assigned to either best medical management alone (including IV rtPA) or intra-arterial treatment (IAT) with mechanical thrombectomy added to best medical management. Each treated patient will be followed and assessed for 3 months after randomization.
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)
盲法说明
The patient and the treating physician will be aware of the treatment assignment. Assessment of outcome on NIHSS and mRS will be performed by a certified rater blinded to the treatment allocation. Each site must designate one or more individual(s) to perform these blinded assessments at 24 (16-36) hours, 6 ± 1 days or discharge (whichever is earlier), 30 days ± 7 days, and 90 days ± 30 days from randomization.
Neuroimaging core lab evaluation will also be assessed in a blinded manner, except for angiographic revascularization grading which will only be performed for the intra-arterial treatment arm.
Information on treatment allocation will be stored separately from the main study database. An unblinded independent statistician will combine treatment allocation data with the clinical data in order to report to the DSMB. A second blinded statistician will be part of the steering committee.
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
- •18 to 85 years of age
- •Presenting with symptoms consistent with an acute ischemic stroke
- •Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1) segment
- •NIHSS score >6 at the time of randomization
- •Ability to randomize within 24 hours of stroke onset
- •Pre-stroke mRS score 0-1
- •Ability to obtain signed informed consent
- •Imaging evidence of moderate-large infarct defined as:
- •1. NCCT ASPECTS 2-5
排除标准
- •Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
- •Known severe allergy (more than a rash) to contrast media uncontrolled by medications
- •Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg)
- •CT evidence of the following conditions:
- •Midline shift or herniation
- •Evidence of intracranial hemorrhage
- •Mass effect with effacement of the ventricles
- •Computed Tomography Angiography (CTA) evidence suggestive of difficult endovascular access per the treating interventionalist
- •Presence of cervical ICA occlusion (e.g., related to atherosclerotic disease or dissection)
- •Rapidly improving neurological status prior to randomization to NIHSS <6
- •Bilateral strokes or multiple intracranial occlusions
- •Intracranial tumors
- •Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >3.0 or Partial Thromboplastin Time (PTT) >3 times of normal
- •Baseline platelet count <30,000 per microliter (µl)
- •Life expectancy less than 90 days prior to stroke onset
- •Participation in another randomized clinical trial that could confound the evaluation of the study
- •Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed
结局指标
主要结局
Utility-weighted 90-day Modified Rankin Score
时间窗: 90 days post randomization
Scale used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scale ranges from 0-6 where 0 represents no symptoms and 6 represents death. 0 = No symptoms at all. 1. = No significant disability despite symptoms; able to carry out all usual duties and activities. 2. = Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3. = Moderate disability requiring some help, but able to walk without assistance. 4. = Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5. = Severe disability; bedridden, incontinent, and requiring constant nursing care and attention. 6. = Death
次要结局
未报告次要终点
研究者
Dr. Osama O. Zaidat
Neuroscience and Stroke Medical Director
Mercy Health Ohio