Intra-Arterial Tenecteplase Following Endovascular Thrombectomy for Large Vessel Occlusion Stroke
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 30-Day Mortality Count
研究概览
简要总结
The purpose of this study is to determine the safety and feasibility of using intra-arterial Tenecteplase in patients undergoing blood clot extraction for treatment of acute ischemic (non-bleeding) stroke. Intravenous Tenecteplase is FDA-approved to treat patients with an ischemic stroke presenting within the 0-3-hour time window.
详细描述
The primary objective of this study is to determine the safety and feasibility of intra-arterial Tenecteplase in selected patients with persistent post-thrombectomy hypoperfusion on computed tomography perfusion based on symptomatic intracranial hemorrhage (parenchymal hematoma type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage producing decline from the initial NIHSS of ≥ 4 points) at 24-36 hours.
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
- Triple (Participant, Investigator, 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
- •Patient/legally authorized representative has signed the Informed Consent Form
- •Ability to comply with the study protocol, in the investigator's judgment
- •Functionally independent (modified Rankin scale 0-2) prior to presentation
- •Baseline National Institutes of Health Stroke Scale (NIHSS) ≥ 6
- •Clinical syndrome consistent with occlusion of the internal carotid artery (ICA) or proximal middle cerebral artery (MCA), presenting within 4.5- to 24-hours of TLKW
- •Evidence of ICA, MCA-M1, or MCA-M2 occlusion on baseline computed tomography angiogram (CTA) or magnetic resonance angiogram (MRA). ICA/MCA tandem occlusions may be enrolled
- •Alberta Stroke Program Early Computed Tomography Score ≥ 6 on pre-thrombectomy unenhanced CT as determined by treating neurologist or reading radiologist
- •Pre-thrombectomy CTP or MRP with core infarction (cerebral blood flow < 30%) < 70 ml, mismatch ratio ≥ 1.8, mismatch volume ≥ 15 ml (completed within 120 minutes of skin puncture for thrombectomy). If skin puncture occurs more than 120 minutes after the pre-thrombectomy CTP, enrollment may proceed at the PI's discretion.
- •Endovascular thrombectomy of ICA, MCA-M1 or MCA-M2 occlusion performed according to local standard of care, defined as at least completing the initial diagnostic angiogram
- •CTP performed with RAPID AI AngioFlowTM within 30 minutes of thrombectomy completion
- •Modified thrombolysis in cerebral infarction (mTICI) 2b-3 revascularization following endovascular thrombectomy (EVT) (or after initial diagnostic angiogram)
- •Presence of Tm > 6 lesion on post-EVT CTP of adequate quality for interpretation in the distribution of the symptomatic occlusion
排除标准
- •Current participation in another investigational drug or device study
- •Known hypersensitivity or allergy to any ingredients of tenecteplase
- •Active internal bleeding
- •Known bleeding diathesis (e.g., Alzheimer's patients taking lecanemab)
- •Systolic blood pressure > 185 mm Hg or diastolic blood pressure > 110 mm Hg after EVT, refractory to medical therapy
- •Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR > 1.7
- •Use of one of the new oral anticoagulants within the last 48 hours (dabigatran, rivaroxaban, apixaban, edoxaban)
- •Treatment with a thrombolytic within the last 3 months prior to randomization
- •Baseline platelet count < 100,000/mcL (results must be available prior to treatment)
- •Baseline blood glucose > 400 mg/dL (22.20 mmol/L)
- •Baseline blood glucose < 50 mg/dL; needs to be normalized prior to randomization
- •Intracranial or intraspinal surgery or trauma within 2 months
- •Intracranial malignant neoplasm, arteriovenous malformation, or unsecured aneurysm > 1 cm
- •Other serious, advanced, or terminal illness (investigator's judgment) or life expectancy is less than 6 months
- •History of acute ischemic stroke in the last 90 days
- •History of hemorrhagic stroke
- •Presumed septic embolus; suspicion of bacterial endocarditis
- •Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was to be performed
- •Acute intracranial hemorrhage on pre-thrombectomy imaging or suspected acute intracranial hemorrhage after EVT
- •Acute bilateral strokes on initial imaging
- •Multiple acute intracranial occlusions (except ICA/MCA) on initial CTA or MRA
- •Significant hemispheric mass effect or any amount of midline shift due to acute stroke
- •Placement of cervical carotid or intracranial stent during thrombectomy procedure requiring dual antiplatelet therapy
研究组 & 干预措施
Intra-arterial Saline
Following endovascular thrombectomy for large vessel occlusion stroke one-time dose of saline (0.9% NaCl solution) will be delivered over 5-10 seconds by the treating neuro-interventionalist through a microcatheter positioned as close as possible to the residual thrombus or as distal as possible in the originating vessel, per the discretion of the neuro-interventionalist.
干预措施: Intra-arterial Saline (Drug)
Intra-arterial Tenecteplase
Following endovascular thrombectomy for large vessel occlusion stroke one-time dose of intra-arterial Tenecteplase (0.125 mg/kg, maximum dose 12.5 mg) will be delivered over 5-10 seconds by the treating neuro-interventionalist through a microcatheter positioned as close as possible to the residual thrombus or as distal as possible in the originating vessel, per the discretion of the neuro-interventionalist.
干预措施: Intra-arterial Tenecteplase (Drug)
结局指标
主要结局
30-Day Mortality Count
时间窗: Day 30
Number of patients expired
Participants with Change in Symptomatic Intracranial Hemorrhage
时间窗: Hour 36
Number of participants with symptomatic intracranial hemorrhage (parenchymal hematoma type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage) producing decline from the initial National Institutes of Health Stroke Scale (NIHSS) of ≥ 4 points.
Participants with Parenchymal Hematoma Type 1
时间窗: 24 Hours
Number of participants with parenchymal hematoma type 1
Participants with Parenchymal Hematoma Type 2
时间窗: 24 Hours
Number of participants with parenchymal hematoma type 2
90-Day Mortality Count
时间窗: Day 90
Number of patients expired
Number of Grade 3 Adverse Events
时间窗: Day 90
Total number of grade 3 adverse events
次要结局
未报告次要终点