Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
NYU Langone Health
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
- Age range
- 18+ years
- Sex
- All
- 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.…
Interventions
- DrugAnticoagulant Therapy
All subjects will receive anticoagulation for a minimum of 3 months.
- DeviceCatheter-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
Locations (40)
- The University of Alabama At BirminghamBirmingham, Alabama
- Stanford MedicinePalo Alto, California
- UC Davis HealthSacramento, California
- Scripps Memorial Hospital, La JollaSan Diego, California
- The Lundquist InstituteTorrance, California
- Christiana CareNewark, Delaware