NCT05591118
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
- Akhilesh Sista - Role: CONTACT - Phone: 212-263-5898 - Email: aks9010@med.cornell.edu
- Sunil Rao - Role: CONTACT - Phone: 212-263-0456 - Email: Sunil.rao@nyulangone.org
PHASE3
RECRUITING
NCT05591118
INTERVENTIONAL
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
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.
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
Pulmonary Embolism
- 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
- NYU Langone Health