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NCT Number: NCT05591118

Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The University of Alabama At Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Anticoagulant Therapy

Drug

All subjects will receive anticoagulation for a minimum of 3 months.

Catheter-Directed Therapy

Device

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

Primary outcomes

  1. Peak Oxygen Consumption (PVO2)

    Time frame: Month 3

    PVO2 measured during cardiopulmonary exercise test (CPET).

  2. New York Heart Association (NYHA) Functional Classification

    Time frame: 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.

  3. Incidence of Major Bleeding at Day 7

    Time frame: Up to 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.

Secondary outcomes

  1. Six-Minute Walk Distance (6MWD)

    Time frame: Month 12

  2. Short-Form Health Survey-36 (SF-36) Score

    Time frame: 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).

  3. Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7

    Time frame: Up to Day 7

    Clinical deterioration defined as hemodynamic decompensation or respiratory decompensation requiring endotracheal intubation.

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Lei

CONTACT

[email protected]

212-263-4189

Sunil Rao

CONTACT

[email protected]

212-263-0456

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: PE-TRACT

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 24, 2022
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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