Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

• Status: Not yet recruiting
• Trial end date: 2028-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NYU Langone Health
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Anticoagulants

Criteria

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. 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