NCT05591118

Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Official Title:

Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

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.

Eligibility

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

Disease(s) and\or Condition(s)

Pulmonary Embolism

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: Anticoagulant Therapy
    • Description: All subjects will receive anticoagulation for a minimum of 3 months.
    • Arm Group Labels: Catheter-Directed Therapy (CDT) plus Anticoagulation, No Catheter-Directed Therapy (No-CDT)
    • Type: DEVICE
    • Name: Catheter-Directed Therapy
    • Description: 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
    • Arm Group Labels: Catheter-Directed Therapy (CDT) plus Anticoagulation
Sponsor
  • NYU Langone Health