Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Purpose

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.

Condition

  • Pulmonary Embolism

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Catheter-Directed Therapy (CDT) plus Anticoagulation 		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.
  • 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
Active Comparator
No Catheter-Directed Therapy (No-CDT) 		Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.
  • Drug: Anticoagulant Therapy
    All subjects will receive anticoagulation for a minimum of 3 months.

Recruiting Locations

The University of Alabama At Birmingham
Birmingham, Alabama 35233
Contact:
Samuel McElwee, MD
205-975-7123
skmcelwee@uabmc.edu

More Details

Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

Akhilesh Sista
212-263-5898
aks9010@med.cornell.edu