Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Drug: Anticoagulant Therapy
* Device: Catheter-Directed Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catheter-Directed Therapy (CDT) plus Anticoagulation<br>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. | Drug: Anticoagulant Therapy<br>* All subjects will receive anticoagulation for a minimum of 3 months.<br>Device: Catheter-Directed Therapy<br>* The endovascular physician can choose to use either mechanical thrombectomy (MT) using a device cleared by the FDA to treat PE or catheter-directed thrombolysis (CDL) using an infusion catheter cleared by the FDA to administer thrombolytic drugs for the treatment of PE<br>|
| Active Comparator: No Catheter-Directed Therapy (No-CDT)<br>Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE. | Drug: Anticoagulant Therapy<br>* All subjects will receive anticoagulation for a minimum of 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Oxygen Consumption (PVO2) | PVO2 measured during cardiopulmonary exercise test (CPET). | Month 3 | 
| New York Heart Association (NYHA) Functional Classification | 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. | Month 12 | 
| Incidence of Major Bleeding at Day 7 | International Society on Thrombosis and Haemostasis (ISTH) definition of Major Bleeding to be used. Per ISTH, Major Bleeding defined as: Fatal bleeding, AND/OR; Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, AND/OR; 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. | Up to Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-Minute Walk Distance (6MWD) |  | Month 12 | 
| Short-Form Health Survey-36 (SF-36) Score | 36-item questionnaire assessing general health. It measures 8 dimensions of health status: social function, physical function, emotional role, physical role, mental health, vitality, physical pain, and general health. Scores range from 0 (worst health status) to 100 (best health status). | Month 12 | 
| Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7 | Clinical deterioration defined as hemodynamic decompensation or respiratory decompensation requiring endotracheal intubation. | Up to Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter-Directed Therapy (CDT)