Safety and Efficacy of Intra-arterial Tenecteplase for Noncomplete Reperfusion of Intracranial Occlusions
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 52
- 主要终点
- Early reperfusion of the residual intracranial occlusion(s)
研究概览
简要总结
TECNO is a multicenter, prospective, randomized, open label, blinded endpoint (PROBE) proof-of-concept trial evaluating if additional administration of intra-arterial Tenecteplase (TNK) improves reperfusion in patients with incomplete mechanical thrombectomy (MT). For this purpose, 156 adult participants experiencing an acute ischemic stroke due to a large vessel occlusion with incomplete reperfusion with residual occlusions after MT will be randomly assigned to receive 3mg intra-arterial (IA) TNK or best medical treatment. Recruitment will occur at 20 academic tertiary stroke care centers in Switzerland, Spain, Belgium, and Germany and patients are followed up for 90 days after the index event. Showing superiority for reperfusion outcomes would have a major impact on the future management of stroke patients.
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)
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
- •Informed consent
- •Age ≥18 years
- •Clinical signs consistent with an acute ischemic stroke
- •Patient had an initial vessel occlusion in the anterior or posterior circulation defined as intracranial ICA, M1, M2, M3, A1, A2, P1 or P2
- •Patient has undergone endovascular stroke treatment
- •Onset to randomization no later than < 705 minutes (11h 45min) after symptom-onset/last-seen well.
- •Incomplete reperfusion defined as any of the following:
- •For ICA/M1: TICI2b/2c (50-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist).
- •For A1/A2, P1/P2, M2/M3: TICI2a/2b/2c (1-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist).
- •Any emboli to new territory without mechanically amendable target-occlusion (as per definition by the interventionalist).
- •Signs of early ischemic changes of non-contrast CT Alberta Stroke Program Early CT Score (ASPECTS) ≥5 (for DWI-ASPECTS ≥ 4, for DWI-ASECTS: a region must have diffusion abnormality in 20% or more of its volume to be considered DWI-ASPECTS positive)
排除标准
- •Acute intracranial hemorrhage
- •Contraindication to MRI (e.g. pacemaker)
- •Any severe bleeding within the past 6 months, which would prevent administration of intravenous thrombolysis in clinical routine Major surgery in the past 2 months with severe risk of bleeding, which would prevent administration of intravenous thrombolysis in clinical routine
- •Intake of Vitamin K antagonists with INR >1.7
- •Platelets < 50,000
- •Non-controlled hypertension (defined as SBP >185 mmHg or DBP >110 mmHg refractory to treatment)
- •Active dyspeptic ulcer
- •Known arterial aneurysm
- •Known neoplasms with risk of bleeding
- •Severe liver fibrosis or portal hypertension
- •Acute pericarditis
- •Acute endocarditis
- •Acute pancreatitis
- •Known allergy to TNK or Gentamicin or other additives/auxiliaries (Polysorbatum 20, L-Argininum, Acidum phosphoricum)
- •Known Renal failure either as defined by a serum creatinine > 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate [GFR] < 30 or as subject who required hemodialysis/peritoneal dialysis
- •Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma)
- •Radiological confirmed evidence of cerebral vasculitis
- •Calcified thrombi
- •Pregnancy or lactating women
研究组 & 干预措施
Intra-arterial Tenecteplase
Patients will receive intra-arterial administration of Tenecteplase using a standard approved microcatheter.
干预措施: Tenecteplase (Drug)
Best Medical Treatment (standard of care)
Patients will receive standard of care as per current ESO guidelines.
结局指标
主要结局
Early reperfusion of the residual intracranial occlusion(s)
时间窗: 25 minutes after randomization
Defined by reperfusion improvement on angiography images
Late reperfusion of the residual intracranial occlusion(s)
时间窗: 24 hours ±6 hours
Defined by complete reperfusion on perfusion imaging
次要结局
- Degree of disability or dependence assessed by the modified ranking scale (mRS) (shift analysis)(90 days+/-15 days)
- Normalized change in National Institute of Health Score Scale (NIHSS)(24 hours +/- 6 hours post-randomization)
- Change in National Institute of Health Score Scale (NIHSS)(90 days +/- 15 days post-randomization)
- Quality of life as assessed by the EuroQol 5D-3L (EQ-5D-3L)(90 days +/- 15 days)
- All-cause mortality(90 days)