NCT05684796已完成不适用
STORM-PE: A Prospective, Multicenter, Randomized Controlled Trial Evaluating Anticoagulation Alone vs Anticoagulation Plus Mechanical Aspiration With the Indigo® Aspiration System for the Treatment of Intermediate High Risk Acute Pulmonary Embolism
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 43
- 主要终点
- Change in RV/LV ratio
研究概览
简要总结
The primary objective of this trial is to evaluate the safety and efficacy of treatment with anticoagulation alone versus anticoagulation and mechanical aspiration thrombectomy with the Indigo Aspiration System for the treatment of intermediate-high risk acute pulmonary embolism (PE).
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old
- •Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
- •Objectively confirmed acute PE, based on computed tomographic pulmonary angiography (CTPA) imaging showing a filling defect in at least one main or proximal lobar pulmonary artery
- •Classification of intermediate high-risk PE as demonstrated by right ventricular dysfunction with RV/LV ratio ≥1.0 on CTPA and elevated cardiac biomarkers, including cardiac troponin, BNP, and/or NT-pro BNP above the upper limit of normal
- •Jugular or femoral access deemed suitable to accommodate pulmonary artery intervention with the Indigo Aspiration System
- •Informed consent is obtained from either the patient or legally authorized representative (LAR)
排除标准
- •Administration of thrombolytic agents or glycoprotein IIb/IIIa receptor antagonist within 30 days prior to baseline imaging
- •Hemodynamic instability with any of the following present:
- •Cardiac arrest
- •Obstructive shock or persistent hypotension defined as systolic blood pressure (BP) <90 mmHg or an acute drop in systolic BP ≥40 mmHg for >15 min, or requiring vasopressor or inotropic support to achieve a systolic BP ≥90 mmHg
- •Patients on ECMO
- •National Early Warning Score (NEWS) 2 ≥9
- •History, imaging or hemodynamic findings consistent with chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
- •Imaging evidence or other evidence that suggests, in the opinion of the Investigator, that catheter-based intervention is not appropriate for the patient
- •Allergy, hypersensitivity, or heparin induced thrombocytopenia (HIT)
- •Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated
- •<45 mL/min creatinine clearance
- •Severe active infection (e.g. sepsis) requiring treatment at time of enrollment
- •Active bleeding or disorders contraindicating anticoagulant therapy
- •Hemoglobin <10 g/dL
- •Platelets <100,000/μL
- •Cardiovascular or pulmonary surgery within last 7 days
- •Primary brain or metastatic brain cancer
- •Life expectancy <90 days
- •Intracardiac thrombus (right atrium, right ventricle clot in transit) or thrombus in the inferior vena cava identified on baseline imaging
- •Current participation in another investigational drug or device trial that may confound the results of this trial. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.
- •Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the trial, including compliance with follow-up requirements, or that could impact the scientific integrity of the trial
研究组 & 干预措施
Anticoagulation (AC)
Active Comparator
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group.
干预措施: Anticoagulation (Drug)
Indigo
Active Comparator
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System.
干预措施: mechanical aspiration thrombectomy (Device)
结局指标
主要结局
Change in RV/LV ratio
时间窗: 48 hours post-randomization
Change in RV/LV ratio at 48 hours on original therapy as assessed by computerized tomography pulmonary angiogram (CTPA)
Change in RV/LV Ratio
时间窗: 48 hours post-randomization
Change in RV/LV ratio at 48 hours on original therapy as assessed by computed tomography pulmonary angiography (CTPA). Negative change values represent a reduction in the ratio of right ventricular to left ventricular diameter, consistent with improvement in right ventricular dilation.
次要结局
- Major Adverse Events(within 7 days post-randomization)
- Functional Outcome Assessment with the New York Heart Association Classification(within 90 days post-randomization)
- Functional Outcome Assessment with the Post Venous Thromboembolism Functional Status scale(within 90 days post-randomization)
- Functional Outcome Assessment with the 6-minute walk test(within 90 days post-randomization)
- Quality of Life Assessment with the Pulmonary Embolism Quality of Life Questionnaire(within 90 days post-randomization)
- Functional Outcome Assessment with the modified Medical Research Council Dyspnea Scale(within 90 days post-randomization)
- Functional Outcome Assessment with the Borg Scale(within 90 days post-randomization)
- Symptomatic PE Recurrence(within 90 days post-randomization)
- Quality of Life Assessment with the EQ-5D-5L Questionnaire(within 90 days post-randomization)
- All-cause Mortality(within 90 days post-randomization)
- PE-related Mortality(within 90 days post-randomization)
- Functional Outcome Assessment With the Modified Medical Research Council Dyspnea Scale(Through 90 days post-randomization)
- Functional Outcome Assessment With the 6-minute Walk Test(Through 90 days post-randomization)
- Functional Outcome Assessment With the New York Heart Association Classification(Through 90 days post-randomization)
- Functional Outcome Assessment With the Post Venous Thromboembolism Functional Status Scale(Through 90 days post-randomization)
- Functional Outcome Assessment With the Borg Scale(Through 90 days post-randomization)
- Quality of Life Assessment With the Pulmonary Embolism Quality of Life Questionnaire(Through 90 days post-randomization)
- Quality of Life Assessment With the EQ-5D-5L Questionnaire(Through 90 days post-randomization)
研究者
研究点 (43)
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