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)
NCT ID: NCT07298096
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
25 participants
INTERVENTIONAL
2026-05-01
2026-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Treatment with Penumbra Element Sheath
Aspiration Thrombectomy
All participants in this study will undergo standard of care aspiration thrombectomy.
Interventions
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Aspiration Thrombectomy
All participants in this study will undergo standard of care aspiration thrombectomy.
Eligibility Criteria
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Inclusion Criteria
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 organ and marrow function as defined below:
1. absolute neutrophil count ≥ 1,000/mcL
2. Platelets ≥ 30,000/mcL
8. As these procedures can be performed without the use of iodinated contrast, there are no specific requirements for renal function
9. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization. Women ≥ 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization.
10. All lines of prior systemic therapy are permissible. Standard concurrent chemotherapy, immunotherapy, or targeted therapy are permissible.
11. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
1. Cardiac arrest
2. Obstructive shock or persistent hypotension defined as systolic blood pressure (BP) \<90 mmHg or an acute drop in systolic BP ≥40 mmHg for \>15 min, or requiring vasopressor or inotropic support to achieve a systolic BP ≥90 mmHg
2. Patients on ECMO
3. History, imaging or hemodynamic findings consistent with chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
4. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, that catheter-based intervention is not appropriate for the patient
a. Including but not limited to large volume lung metastases, especially in vascular distribution, large volume pulmonary infarct
5. Allergy, hypersensitivity, or heparin induced thrombocytopenia (HIT)
6. Severe active infection (e.g. sepsis) requiring treatment at time of enrollment
7. Absolute neutrophil count \<1000 mm3 within 6 weeks of screening
8. Life expectancy \<90 days
9. Pregnancy
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Varshana Gurusamy, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Varshana Gurusamy, MD
Role: primary
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2025-08931
Identifier Type: OTHER
Identifier Source: secondary_id
2025-0830
Identifier Type: -
Identifier Source: org_study_id