A Prospective Single Center, Single Arm, Single-institution Registry That Aims to Assess the Safety and Quality of Life Benefits of Computer-assisted Vacuum Thrombectomy (CAVT) in the Treatment of Cancer Patients With Intermediate Risk Pulmonary Embolism (PE)
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to gather information about the quality of life benefits of cancer patients with intermediate risk PE who underwent thrombectomy. The safety of thrombectomy in this patient population will also be studied.
Description
Primary Objective: To assess the change in the Post Venous Thromboembolism Functional Status (PFVS, see Appendix) score at the time of discharge. Secondary Objectives: 1. To evaluate quality of life outcomes in patients undergoing thrombectomy by assessing changes in RV/LV ratio from baseline to 48 hours and 90 days post-procedure. 2. To compare PE-related mortality versus all-cause mortality. 3. To assess the incidence of device-related complications and rate of major bleeding events. 4. To assess safety by determining the incidence of major adverse events within 7 days post-treatment. 5.…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with current or prior diagnosis of cancer 2. Confirmed PE, based on computed tomographic pulmonary angiography (CTPA) imaging showing a filling defect in at least one main or proximal lobar pulmonary artery 3. Classification of intermediate risk PE as defined by the institutional PERT algorithm 4. Candidate for standard of care pulmonary thrombectomy 5. Age greater than or equal to 18 years. The devices for mechanical thrombectomy are not suitably sized for pediatric patients. 6. ECOG performance status less than or equal to 3 7. Patients must have adequate org…
Interventions
- ProcedureAspiration Thrombectomy
All participants in this study will undergo standard of care aspiration thrombectomy.
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas