2023-504262-32-01招募中3 期
CHemical OptImization of Cerebral Embolectomy in patients with acute stroke treated with mechanical thrombectomy 2 (CHOICE2TRIAL)
Foundation Clinic For Biomedical Research14 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2023年10月19日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 440
- 试验地点
- 14
- 主要终点
- Proportion of patients with a mRS 0 to 1 at 90 days.
研究概览
简要总结
The study objective is to evaluate whether rt-PA is efficient as an add-on to mechanical thrombectomy in patients with acute ischemic stroke and recanalization with complete or near-complete reperfusion of a proximal vessel occlusion on cerebral angiogram (corresponding to mTICI score 2b/3).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic large vessel occlusion (LVO) in the anterior circulation (TICA, ACA or MCA) treated with MT resulting in a mTICI angiographic score 2b/3 at end of the procedure.
- •Estimated delay to onset of rescue IA rt-PA administration <24 hours from symptom onset, defined as the point in time the patient was last seen well.
- •No significant pre-stroke functional disability (modified Rankin scale 0-1, or mRS >1 that according to the investigator is not related to neurological disease (i.e. amputation, blindness))
- •ASPECTS ≥6 on non-contrast CT (NCCT) scan if symptoms lasting <4.5 hours of last seen well. In patients with >4.5h of last seen well, a CT-perfusion (Flow maps) or MRI-perfusion should be considered, especially if >9h have elapsed, or in seriously ill patients (i.e., NIHSS>17). If a perfusion study is not available before MT, NCCT can still be used if the ASPECTS is ≥
- •Informed consent obtained from patient or acceptable patient surrogate.
排除标准
- •NIHSS score on admission >25
- •Renal Failure as defined by a serum creatinine > 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate [GFR] < 30
- •Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason
- •Any hemorrhage on CT/MRI
- •Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
- •Suspicion of aortic dissection
- •Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol
- •History of life-threatening allergy (more than rash) to contrast medium
- •SBP >185 mmHg or DBP >110 mmHg refractory to treatment
- •Serious, advanced, terminal illness with anticipated life expectancy < 6 months
- •Pre-existing neurological or psychiatric disease that would confound evaluation
- •Contraindication to IV t‐PA as per local national guidelines (except time to therapy)
- •Presumed vasculitis or septic embolization
- •Unlikely to be available for 90-day follow-up (i.e., no fixed home address, visitor from overseas)
- •Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy during the first 24h
- •Need of more than 3 passes (per vessel) or more than a total of 5 passes (in more than one vessel) to complete the endovascular procedure
- •Female who is pregnant or lactating or has a positive pregnancy test at time of admission
- •Current participation in another investigation drug or device treatment study
- •Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
- •Known coagulopathy, or INR > 1.7
- •Platelets < 50,000
结局指标
主要结局
Proportion of patients with a mRS 0 to 1 at 90 days.
Proportion of patients with a mRS 0 to 1 at 90 days.
次要结局
- •Proportion of patients with abnormal microvascular hypoperfusion on CT Perfusion at 36±24h post MT. • Volume of hypoperfusion on brain CTP at 36h±24h post MT •Infarct Expansion Ratio (IER): Final infarct to initial ischemic tissue volumes on brain NCCT at 36±24h post MT. •Barthel Scale score of 95 to 100, at day 90. •Quality of life measured with the EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 90 days. •The shift analysis of the modified Rankin Scale (mRS), at day 90.
研究者
Dr. Ángel Chamorro
Scientific
Foundation Clinic For Biomedical Research
研究点 (14)
Loading locations...
相似试验
进行中（未招募）
1 期
Mejoría química del tratamiento que recanaliza (destapa”) las arterias cerebrales en pacientes con ictus agudo tratados con diferentes dispositivos que permiten la extracción mecánica del trombo cerebralCerebral Embolectomy in patients with acute strokeEUCTR2018-002195-40-ESFundació Clínic per a la Recerca Biomèdica200
已完成
2 期
Intraarterial Alteplase Versus Placebo After Mechanical ThrombectomyStroke, AcuteNCT03876119Hospital Clinic of Barcelona121
尚未招募
2 期
Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure ManagementStrokeNCT07279259Shanghai East Hospital340
招募中
1 期
CHemical OptImization of Cerebral Embolectomy in patients with acute stroke treated with mechanical thrombectomy 2 (CHOICE2TRIAL)Cerebral Embolectomy in patients with acute strokeCTIS2023-504262-32-01Foundation Clinic For Biomedical Research440
尚未招募
不适用
Transarterial Chemoembolization With Low-Dose Bevacizumab Plus Atezolizumab as First-Line Treatment for Unresectable Hepatocellular CarcinomaHepatocellular CarcinomaNCT07281664Third Affiliated Hospital, Sun Yat-Sen University30