NCT07298096

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. To compare pre- and post-procedure oxygen requirements and six-minute walk test (6MWT) performance in ambulatory patients. 6. To evaluate radiographic changes over time on CT imaging, including parenchymal perfusion and RV/LV ratio in patients undergoing different treatment, at three-time points baseline, 48 hours, and 90 days. 7. To compare BORG Dyspnea Scale scores between pre- and 90-day post-treatment. 8. To evaluate the rate of PE recurrence within 90 days. 9. To evaluate changes in residual volume of PE from baseline to follow-up imaging. 10. To assess the incidence and severity of bleeding events using the BARC (Bleeding Academic Research Consortium) classification, and to explore associations between bleeding events and patients' chemotherapy or immunotherapy regimens through subgroup analysis. 11. To characterize the histopathologic features of retrieved thrombus specimens, categorizing them as either bland thrombus or tumor thrombus, and further classifying tumor thrombi by histologic origin, such as gastrointestinal (GI) or genitourinary (GU) malignancies. 12. To evaluate the reduction in RV/LV ratio on 48-hour post-treatment CT.

Conditions

• Cancer

Interventions

Type	Name	Description
PROCEDURE	Aspiration Thrombectomy	All participants in this study will undergo standard of care aspiration thrombectomy.

Timeline

• Start date: 2026-01-08
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-12-23
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States