Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 77
- 主要终点
- New York Heart Association (NYHA) Functional Classification
研究概览
简要总结
PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and
- •Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio > 1 on CT angiography
排除标准
- •Age < 18 years
- •Systolic blood pressure < 90 mmHg for >15 consecutive minutes or > 40 mmHg drop from baseline, or vasopressor requirement for blood pressure support (i.e., massive PE), occurring within 1 hour prior to eligibility assessment.
- •Symptom duration > 14 days for the current PE episode
- •Irreversible INR > 3
- •Irreversible Thrombocytopenia (Platelets < 50,000/microliter)
- •Creatinine > 2.0 mg/dl
- •Hemoglobin < 7.0 g/dl
- •Pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential))
- •Allergy or hypersensitivity to Recombinant Tissue Plasminogen Activator (rt-PA), or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used
- •Life expectancy < 1 year
- •Chronic inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound)
- •Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT)
- •Unable or unwilling to provide informed consent
- •Major contraindication or unsuitability for all CDT methods available at the Clinical Center
研究组 & 干预措施
No Catheter-Directed Therapy (No-CDT)
Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.
干预措施: Anticoagulant Therapy (Drug)
Catheter-Directed Therapy (CDT) plus Anticoagulation
Participants will receive CDT consisting of mechanical thrombectomy (MT) or intrathrombus catheter-directed thrombolysis (CDL) using FDA-cleared devices for pulmonary embolism (PE). The exact technique and devices used will be at the discretion of the endovascular physician, within parameters defined by the PE-TRACT Manual of Operations (MOP) and accepted standard care. Before and after CDT, patients will receive standard PE therapy as in the no-CDT Arm.
干预措施: Anticoagulant Therapy (Drug)
Catheter-Directed Therapy (CDT) plus Anticoagulation
Participants will receive CDT consisting of mechanical thrombectomy (MT) or intrathrombus catheter-directed thrombolysis (CDL) using FDA-cleared devices for pulmonary embolism (PE). The exact technique and devices used will be at the discretion of the endovascular physician, within parameters defined by the PE-TRACT Manual of Operations (MOP) and accepted standard care. Before and after CDT, patients will receive standard PE therapy as in the no-CDT Arm.
干预措施: Catheter-Directed Therapy (Device)
结局指标
主要结局
New York Heart Association (NYHA) Functional Classification
时间窗: Month 12
The NYHA classifies the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain: * Class I - No symptoms and no limitation with ordinary physical activity. * Class II - Mild symptoms and slight limitation during ordinary activity. * Class III - Moderate limitation in activity (even less than ordinary) due to symptoms. * Class IV - Symptoms occur at rest and severe limitation with any physical activity. * Class V - Dead.
Incidence of Major Bleeding at Day 7
时间窗: Up to Day 7
International Society on Thrombosis and Haemostasis (ISTH) definition of "Major Bleeding" to be used. Per ISTH, Major Bleeding defined as: 1. Fatal bleeding, AND/OR; 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, AND/OR; 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
Peak Oxygen Consumption (PVO2)
时间窗: Month 3
PVO2 measured during cardiopulmonary exercise test (CPET).
次要结局
- Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7(Up to Day 7)
- Short-Form Health Survey-36 (SF-36) Score(Month 12)
- Six-Minute Walk Distance (6MWD)(Month 12)