Clinical Research Studies

Site for PE TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare CDT and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation. Primary Objective: Determine whether patients with submassive PE who are treated with CDT plus medical therapy (CDT group) have better cardiopulmonary health in the year following PE than patients treated with medical therapy alone (No-CDT). Primary Safety Objective: Determine whether CDT is associated with a higher rate of major adverse events at 7 days than No-CDT Secondary Objectives: Determine: 1) Whether patients treated with CDT have better generic quality of life than No-CDT2) Rates of clinical deterioration in the first 7 days in both groups. 3) The cost-effectiveness of CDT compared with No-CDT. 4) Length of 6MWD at 12 months in both groups. Primary Efficacy Outcomes: At 3 months: Peak oxygen uptake (PVO2) on cardiopulmonary exercise testing and at 12 months: New York Heart Association (NYHA) class The primary safety outcome will be major bleeding within 30 days of randomization. Secondary outcomes include generic quality of life (QOL) (SF-36), 6-minute walk distance, clinical deterioration from PE, and cost-effectiveness. Exploratory analyses will assess: disease-specific QOL, other cardiopulmonary exercise test parameters, recurrent venous thromboembolism and complications of the CDT procedure. Predictors of therapeutic response will also be sought. The safety endpoints are major, intracranial, and minor bleeding, and CDT related complications.