NCT05907564进行中（未招募）不适用
Evaluate the Safety and Efficacy of the Aventus Thrombectomy System for Aspiration Thrombectomy in Subjects With Acute Pulmonary Embolism
Inquis Medical, Inc.26 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年9月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 26
- 主要终点
- Change in RV/LV Ratio
研究概览
简要总结
Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 80 years
- •Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures
- •Subject is willing and able to comply with all protocol required follow-up visits
- •PE (pulmonary embolism) symptom(s) duration ≤ 14 days from index procedure
- •PE diagnosis ≤ 48 hours prior to index procedure
- •CTA (computed tomography angiography) evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery based on Investigator determination)
- •CTA evidence of dilated RV (right ventricle) with an RV/LV (left ventricle) ratio of ≥ 0.9 at baseline based on Investigator determination
- •Systolic blood pressure (SBP) ≥ 90 mmHg without need for vasopressors (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with intravenous fluids prior to index procedure)
- •Stable heart rate < 130 BPM prior to index procedure
- •Subject is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment
排除标准
- •Prior PE ≤ 180 days from index procedure
- •Current hospitalization for other condition(s)
- •Thrombolytic use ≤ 14 days of baseline CTA
- •Pulmonary hypertension with peak pulmonary artery systolic pressure > 70 mmHg by right heart catheterization
- •FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
- •Hematocrit < 28% within 6 hours of index procedure
- •Platelets < 100,000/μL
- •Serum creatinine > 1.8 mg/dL
- •International normalized ratio (INR) > 3
- •Presence of intracardiac lead in the right ventricle or right atrium placed < 180 days prior to index procedure
- •Cardiovascular or pulmonary surgery ≤ 7 days prior to index procedure
- •Actively progressing cancer treated by chemotherapeutics
- •Known bleeding diathesis or coagulation disorder
- •Left bundle branch block
- •History of severe or chronic 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
- •History of chest irradiation
- •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
- •Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for aspiration thrombectomy intervention such as the inability to navigate to target location, predominantly 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 that has not reached the primary endpoint or the Investigator feels would impact their ability to participate in this clinical trial
- •Subject has known residual Iliac Deep Vein Thrombosis (DVT), Inferior Vena Cava (IVC) clot or clot in transit (right atrium and/or right ventricular)
- •Subject on extracorporeal membrane oxygenation (ECMO)
研究组 & 干预措施
Single Arm
Experimental
Device: Aventus Thrombectomy System
干预措施: Thrombectomy (Device)
结局指标
主要结局
Change in RV/LV Ratio
时间窗: From Baseline to 48 hours
Change in RV/LV Ratio per CTA
Major Adverse Event Rate
时间窗: From Index Procedure to 48 hours
Composite of device related MAEs including death, major bleed, clinical deterioration, pulmonary vascular injury, and cardiac injury
Change in RV/LV Ratio
时间窗: at 48hrs compared to baseline
Mean Change in RV (right ventricle)/LV(left ventricle) Ratio at 48hrs compared to baseline
Device Related Major Adverse Event Rate
时间窗: From Index Procedure to 48 hours
Composite of device related MAEs (major adverse events) including death, major bleed, 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 (26)
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