FlowTriever Pulmonary Embolectomy Clinical Study - FlowTriever2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 14
- 主要终点
- Primary Safety Endpoint (Composite): Incidence of Adjudicated Serious Adverse Events (SAE)
研究概览
简要总结
The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of the FlowTriever2 Catheter for mechanical thrombectomy of pulmonary embolism (PE).
详细描述
The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the FlowTriever2 Catheter for mechanical thrombectomy in patients eligible for endovascular treatment of acute pulmonary embolism (PE). The subjects who meet the inclusion/exclusion criteria will be enrolled in the study. The enrollment period is over a period of approximately 12 months. All study subjects actively participate through the 30-day visit (-5 / +15 days) following treatment. Study participation includes screening, baseline, treatment, 48-hour visit, and 30-day follow-up. The study population consists of subjects that have an acute PE. Subject eligibility is determined based on data available to the Investigator at the time of enrollment. Subjects must meet all inclusion and no exclusion criteria to be eligible for the study. All subjects that complete the procedure and the follow-ups are included in the analysis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs and symptoms consistent with acute PE
- •PE symptom duration ≤ 14 days
- •CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
- •RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment based on Investigator's interpretation of RV/LV ratio)
- •Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
- •Stable heart rate < 130 BPM prior to procedure
- •Patient is deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment.
- •FlowTriever2 Catheter enters the vasculature
排除标准
- •Thrombolytic use within 30 days of baseline CTA
- •Pulmonary hypertension with peak pulmonary artery 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 6 hours of index procedure)
- •Platelets < 100,000/μL
- •Serum creatinine > 1.8 mg/dL
- •Major trauma Injury Severity Score (ISS) > 15
- •Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
- •Cardiovascular or pulmonary surgery within last 7 days
- •Actively progressing cancer
- •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 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 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
结局指标
主要结局
Primary Safety Endpoint (Composite): Incidence of Adjudicated Serious Adverse Events (SAE)
时间窗: Device-related mortality and device-related major bleeding components assessed through 48 hours after index procedure. Intra-procedural device or procedure-related AE component assessed until index procedure completion (index procedure: approx. 50 mins).
Incidence of adjudicated Serious Adverse Events (SAE), which is a composite of: * Mortality through 48 hours after the index procedure related to FlowTriever2 Catheter * Major bleeding through 48 hours after the index procedure related to FlowTriever2 Catheter * Intra-procedural device or procedure-related adverse events, including: * Clinical deterioration defined by hemodynamic or respiratory worsening * Pulmonary vascular injury related to FlowTriever2 Catheter * Cardiac injury related to FlowTriever2 Catheter
Primary Effectiveness Endpoint: Change in Mean Pulmonary Arterial Pressure (mmHg)
时间窗: Intraprocedural (at beginning and end of treatment procedure (index procedure: approximately 50 minutes))
Change in mean pulmonary arterial pressure measured via right heart catheterization at the beginning of the treatment procedure and at the end of the treatment procedure.
次要结局
- Secondary Safety Endpoint: Number of Symptomatic Recurrences of PE(30 days post procedure (-5 / +15 days))
- Secondary Safety Endpoint: Number of Patient Mortalities(30 days post procedure (-5 / +15 days))
- Secondary Safety Endpoint: Number of Device-Related Serious Adverse Events(30 days post procedure (-5 / +15 days))
- Secondary Safety Endpoint: Number of Device-Related Serious Adverse Events(30 days post procedure (-5 / +15 days))
- Secondary Safety Endpoint: Number of Patient Mortalities(30 days post procedure (-5 / +15 days))
- Secondary Safety Endpoint: Number of Symptomatic Recurrences of PE(30 days post procedure (-5 / +15 days))
- Secondary Effectiveness Endpoint: Change in Systolic Pulmonary Arterial Pressure (mmHg)(Intraprocedural (at beginning and end of treatment procedure (index procedure: approximately 50 minutes)))
- Secondary Effectiveness Endpoint: Number of Patients With Adjunctive Thrombolytic Use(During Procedure (index procedure: approximately 50 minutes))