Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of any intracranial hemorrhage and neurologic worsening
研究概览
简要总结
Prospective, single center, non-randomized, pilot study to assess the feasibility of IA TNK following standard of care mechanical thrombectomy (MT) in patients with AIS. Participants will receive IA TNK after achieving mTICI 2b or 2c reperfusion with standard of care MT. Patients enrolled into the study will be followed for 3 months after treatment with IA TNK.
详细描述
As current MT technology is not amenable to retrieval of distal occlusions (M3/M4, etc), we hypothesize that IA lytic may play an important role as an adjunctive therapy to open up distal vessels (after the primary LVO has been removed) to achieve complete or near complete reperfusion. In this pilot trial, our goal is to assess the feasibility and safety of IA Tenecteplase (TNK) as an adjunctive therapy following standard of care mechanical thrombectomy (MT) in patients with AIS. A total of 20 patients will be enrolled into the ALLY pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •1. Age 18-85
- •2. Anterior circulation ischemic stroke symptoms with confirmed occlusion (ICA, M1, or M2) on angiogram and mechanical thrombectomy initiated within 24 hours since last known well
- •3. a. Patients treated less than 6 hours since last known well with ASPECTS >
- •b. Patients treated beyond 6 hours since last known well, CT or MRI perfusion scan showing favorable mismatch profile (Target mismatch profile on CT perfusion or MRI (ischemic core volume is <70ml, mismatch ratio is >1.8 and mismatch volume is >15ml)
- •4. Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or 2c with persistent occlusion(s) in terminal branches not amenable to MT.
- •5. Signed informed consent
排除标准
- •1. Premorbid modified Rankin scale (mRS) score of 4 or greater
- •2. Presence of any hemorrhage and/or ASPECT score ≤6 on baseline head CT
- •3. Platelet count <100,000
- •4. Known bleeding diathesis
- •5. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
- •6. Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR >1.8
- •7. Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting)
- •8. Pregnant or lactating
- •9. Previous known allergy to TNK
- •10. Major surgery in past 30 days
- •11. Patient is on or requires dialysis
- •12. History of intracranial hemorrhage or serious head trauma at any time
- •13. Any condition in the opinion of the enrolling physician that would preclude the patient from participating
- •14. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluation
- •15. Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) that is refractory to treatment
- •16. History of acute ischemic stroke in the last 60 days
- •17. Presumed septic embolus; suspicion of bacterial endocarditis
- •18. Suspicion of aortic dissection
- •19. Intracranial neoplasm
- •20. Any mass effect
- •21. Any terminal medical condition with life expectancy less than 6 months
- •22. Concurrent enrollment in another trial that could confound the results of this study
研究组 & 干预措施
Intra-arterial Tenecteplase
Participants will receive intra-arterial Tenecteplase after achieving mTICI 2b or 2c reperfusion with standard of care MT.
干预措施: intra-arterial tenecteplase (Drug)
结局指标
主要结局
Incidence of any intracranial hemorrhage and neurologic worsening
时间窗: 24 hours post-treatment with intra-arterial Tenecteplase
Incidence of any intracranial hemorrhage and neurologic worsening of at least 4 points on the National Institute of Health Stroke Scale (NIHSS), according to the European Cooperative Acute Stroke Study II (ECASS-II) criteria, within 24 hours of treatment with IA TNK
Incidence of Any Intracranial Hemorrhage and Neurologic Worsening
时间窗: 24 hours (+/- 8 hours) post-treatment with intra-arterial Tenecteplase
Number of participants with any incidence of intracranial hemorrhage and neurologic worsening of at least 4 points on the National Institute of Health Stroke Scale (NIHSS), according to the European Cooperative Acute Stroke Study II (ECASS-II) criteria, within 24 hours (+/- 8 hours) of treatment with IA TNK. This measure was assessed by imaging (NCCT/MRI) done within this time frame for all the enrolled study participants. This is the primary study-specific baseline measure for the ALLY study.
次要结局
- Improved reperfusion(immediate post-treatment)
- Ordinal modified Rankin Scale Score(90 days post-treatment)
- Functional Independence(90 days post-treatment)
- Final revascularization grade(immediate post-treatment)
- Mortality(Hospital Discharge (Day 6 post-randomization (+/- 1 day)))
- Asymptomatic intracranial hemorrhage(24 hours post-treatment)
- Mean number of boluses(Immediate post-procedure)
- Ordinal Modified Rankin Scale Score(90 days (+/- 30 days) post-treatment)
- Final Revascularization Grade(immediate post-treatment)
- Incidence of Any Asymptomatic Intracranial Hemorrhage(24-Hour (+/- 8 hours) post-treatment)
- Number of Boluses(Immediate post-procedure)
- Mortality Rate at Discharge(Hospital Discharge (+/-1 day))