NCT05597891已完成不适用
A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device For the Treatment of Pulmonary Embolism (ENGULF)
Endovascular Engineering31 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2023年1月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 31
- 主要终点
- Primary Performance Objective
研究概览
简要总结
Evaluation of initial safety and clinical feasibility of the Hēlo PE Thrombectomy System for thrombectomy in acute submassive pulmonary embolism (PE).
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asterisks * indicate entry criteria that can be evaluated during prescreening without obtaining informed consent as they are part of standard of care PE management. Asterisks in parenthesis (*) indicate entry criteria that can be evaluated during prescreening without obtaining informed consent at Sites that routinely perform CTA as part of standard of care in PE management.
- •Inclusion Criteria:
- •Patients must meet ALL of the following criteria to be eligible for participation in the study:
- •*Patient is > 18 and < 90 years old
- •*Clinical signs and symptoms consistent with acute submassive PE with duration ≤ 14 days, as determined by the Investigator
- •(*)CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
- •(*)RV/LV ratio of ≥ 0.9 (Enrollment qualification assessment based on Investigator's interpretation of RV/LV ratio at baseline)
- •*Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
- •*Heart rate < 130 BPM prior to procedure
- •*Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment
- •Patient signs a written Informed Consent form to participate in the study, prior to any study mandated procedures
排除标准
- •Patients must be EXCLUDED from participation in this study if ANY of the following criteria are met:
- •*Acute massive PE at presentation
- •*Prior PE within last 6 months
- •*Thrombolytic use within 30 days of baseline CTA
- •*Pulmonary hypertension with peak pulmonary artery systolic pressure > 70 mmHg by right heart catheterization
- •*Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
- •*FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
- •*Hematocrit < 28% (NOTE: hematocrit required within 24 hours of index procedure)
- •*Platelets < 100,000/μL
- •*Serum creatinine > 1.8 mg/dL
- •*International normalized ratio (INR) > 3
- •*aPTT (or PTT) > 50 seconds on no anticoagulation
- •*Major trauma < 14 days
- •*Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
- •*Cardiovascular or pulmonary surgery within last 7 days
- •*Life expectancy less than 1 year due to advanced malignancy, as determined by the investigator at the time of enrollment
- •*Known bleeding diathesis or coagulation disorder
- •*Known left bundle branch block
- •*History of severe pulmonary arterial hypertension
- •*History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
- •*History of uncompensated heart failure
- •*History of underlying lung disease that is oxygen dependent
- •*Presence of IVC filter and or iliocaval stents
- •*History of heparin-induced thrombocytopenia (HIT)
- •*Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
- •*Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
- •*Known allergy to any device component
- •(*)Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location, predominately chronic clot or non-clot embolus)
- •*Life expectancy of < 90 days, as determined by Investigator
- •*Female who is pregnant or nursing
- •*Current participation in another investigational drug or device treatment study
研究组 & 干预措施
Investigational Device
Experimental
The study design includes two cohorts: a Pre-Pivotal Cohort of up to 50 subjects (25 Feasibility and up to 25 Roll-Ins), and a Pivotal Cohort enrolling up to 170 subjects, to yield 100 evaluable subjects at 48 hours post procedure treated with the Helo PE Thrombectomy System and no less than 40 subjects treated with blood reinfusion via the Helo BRS.
干预措施: Hēlo PE Thombectomy System (Device)
结局指标
主要结局
Primary Performance Objective
时间窗: 48 hours following the procedure
Clinical Success, defined as the reduction in RV/LV ratio from baseline to 48 hours (+/- 24 hours, or discharge, whichever occurs first) as assessed by CTA
Primary Safety Objective
时间窗: 48 hours following the procedure
Composite device-related Major Adverse Event (MAE) rate, defined as any of the following events within 48 hours (+/- 24 hours) of the procedure: * Death * Life-threatening, disabling or major bleeding as defined by VARC-2 * Serious adverse events, including, clinical deterioration, pulmonary vascular injury, and cardiac injury
次要结局
未报告次要终点
研究者
研究点 (31)
Loading locations...
相似试验
已完成
不适用
transShield Embolic Protection System Feasibility StudyAortic StenosisNCT04585308TransAortic Medical, Inc.28
进行中（未招募）
不适用
(HALT) Embrace Hydrogel Embolic System (HES) Study of Embolization in Peripheral Arterial BleedsArterial Bleeding in Solid Organs and Peripheral ArteriesNCT05364502Instylla, Inc.130
尚未招募
不适用
Investigating Efficacy and Safety of JETi® in Arterial Occlusions in FEM-POP and Prox BTK-Lesions (JETART)Peripheral Arterial DiseaseNCT06434779Vascular Science LP GmbH200
终止
不适用
Amnis Therapeutics Thrombectomy Device-First in Man (FIM) Safety and Performance StudyIschemic StrokeNCT02994563Amnis Therapeutics5
撤回
不适用
Large-Bore Mechanic Thrombectomy for the Treatment of Symptomatic Portomesenteric Vein ThrombosisThrombosisThrombectomyPortal VeinNCT06318754University of Maryland, Baltimore10