Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Overview

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.

Interventions

• Drug Anticoagulant Therapy
  All subjects will receive anticoagulation for a minimum of 3 months.
• Device Catheter-Directed Therapy
  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 outcome measures

• Peak Oxygen Consumption (PVO2) [Time frame: Month 3]
• New York Heart Association (NYHA) Functional Classification [Time frame: Month 12]
• Incidence of Major Bleeding at Day 7 [Time frame: Up to Day 7]

Secondary outcome measures (3)

• Six-Minute Walk Distance (6MWD) [Time frame: Month 12]
• Short-Form Health Survey-36 (SF-36) Score [Time frame: Month 12]
• Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7 [Time frame: Up to Day 7]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 40 centers

• The University of Alabama At Birmingham — Birmingham
• Stanford Medicine — Palo Alto
• UC Davis Health — Sacramento
• Scripps Memorial Hospital, La Jolla — San Diego
• The Lundquist Institute — Torrance
• Christiana Care — Newark
• MedStar Health Research Institute — Washington D.C.
• Baptist Health Miami Cardiac & Vascular Institute — Miami
• … and 32 more centers

Publications

• Sista AK, Troxel AB, Tarpey T, Parpia S, Goldhaber SZ, Stringer WW, Magnuson EA, Cohen DJ, Kahn SR, Rao SV, Morris TA, Goldfeld KS, Vedantham S. Rationale and design of the PE-TRACT trial: A multicenter randomized trial to evaluate catheter-directed therapy for the treatment of intermediate-risk pulmonary embolism. Am Heart J. 2025 Mar;281:112-122. doi: 10.1016/j.ahj.2024.11.016. Epub 2024 Dec 3. PMID 39638275

Identifiers

NCT: NCT05591118 · 22-01272

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗