Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy (PE-TRACT)

NYU Langone Health

Status and phase: Enrolling; Phase 3

Conditions: Pulmonary Embolism

Treatments: Drug: Anticoagulant Therapy; Device: Catheter-Directed Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05591118

22-01272

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Catheter-Directed Therapy (CDT) plus Anticoagulation

Experimental group

Description:

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.

Treatment:

Device: Catheter-Directed Therapy

Drug: Anticoagulant Therapy

No Catheter-Directed Therapy (No-CDT)

Active Comparator group

Description:

Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.

Treatment:

Drug: Anticoagulant Therapy