Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Phase 3

Recruiting

• Conditions: Pulmonary Embolism
• Interventions: Drug: Anticoagulant Therapy; Device: Catheter-Directed Therapy

• Registration Number: NCT05591118
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-24
• Study Start: 2023-07-17
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-19
• Primary Completion: 2027-03-29
• Study Completion: 2027-06-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and
2. Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio > 1 on CT angiography

Exclusion Criteria

1. Age < 18 years
2. 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.
3. Symptom duration > 14 days for the current PE episode
4. Irreversible INR > 3
5. Irreversible Thrombocytopenia (Platelets < 50,000/microliter)
6. Creatinine > 2.0 mg/dl
7. Hemoglobin < 7.0 g/dl
8. Pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential))
9. 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
10. Life expectancy < 1 year
11. Chronic inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound)
12. Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT)
13. Unable or unwilling to provide informed consent
14. Major contraindication or unsuitability for all CDT methods available at the Clinical Center

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Catheter-Directed Therapy (No-CDT)	Anticoagulant Therapy	Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.
Catheter-Directed Therapy (CDT) plus Anticoagulation	Anticoagulant Therapy	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.
Catheter-Directed Therapy (CDT) plus Anticoagulation	Catheter-Directed Therapy	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.

Primary Outcome Measures

Name	Time	Method
New York Heart Association (NYHA) Functional Classification	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	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)	Month 3	PVO2 measured during cardiopulmonary exercise test (CPET).

Secondary Outcome Measures

Name	Time	Method
Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7	Up to Day 7	Clinical deterioration defined as hemodynamic decompensation or respiratory decompensation requiring endotracheal intubation.
Short-Form Health Survey-36 (SF-36) Score	Month 12	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).
Six-Minute Walk Distance (6MWD)	Month 12

Trial Locations

Locations (40)

The University of Alabama At Birmingham; 🇺🇸 Birmingham, Alabama, United States

Stanford Medicine; 🇺🇸 Palo Alto, California, United States

UC Davis Health; 🇺🇸 Sacramento, California, United States

Scripps Memorial Hospital, La Jolla; 🇺🇸 San Diego, California, United States

The Lundquist Institute; 🇺🇸 Torrance, California, United States

Christiana Care; 🇺🇸 Newark, Delaware, United States

MedStar Health Research Institute; 🇺🇸 Washington, District of Columbia, United States

Baptist Health Miami Cardiac & Vascular Institute; 🇺🇸 Miami, Florida, United States

University of South Florida/ Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

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