Computer-assisted vacuum thrombectomy for intermediate-risk pulmonary embolism in cancer patients

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)

This study will try computer-assisted vacuum thrombectomy in adults with current or prior cancer and intermediate-risk pulmonary embolism to see if it is safe and improves quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT07298096 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center, single-arm registry at M.D. Anderson Cancer Center enrolling adults with current or prior cancer who have intermediate-risk pulmonary embolism and are candidates for aspiration thrombectomy. Participants will undergo computer-assisted vacuum thrombectomy and be followed with clinical assessments, imaging, and functional tests at baseline, 48 hours, and 90 days. The primary outcome is change in the Post Venous Thromboembolism Functional Status (PVFS) score at discharge, with secondary outcomes including RV/LV ratio changes, mortality, bleeding and device-related complications, oxygen requirements, six-minute walk test performance, CT-based perfusion metrics, PE recurrence, and histopathology of retrieved thrombus. Eligibility requires age ≥18, ECOG ≤3, adequate blood counts, and PE classified as intermediate risk by the institutional PERT algorithm.

Who should consider this trial

Good fit: Adults (≥18) with current or prior cancer who have confirmed intermediate-risk pulmonary embolism per the institutional PERT pathway, are candidates for thrombectomy, have ECOG ≤3, and meet basic blood-count thresholds (ANC ≥1,000/mcL and platelets ≥30,000/mcL).

Not a fit: Patients who are low-risk for PE, are not candidates for mechanical thrombectomy, have very poor functional status (ECOG >3) or profound cytopenias (platelets <30,000/mcL) may not receive benefit from this procedure.

Why it matters

Potential benefit: If successful, the procedure could lower clot burden and right-heart strain, reduce symptoms, and improve short-term quality of life for cancer patients with intermediate-risk PE.

How similar studies have performed: Mechanical aspiration thrombectomy has shown promise in improving RV function and symptoms in noncancer PE populations, but data specifically on computer-assisted vacuum thrombectomy in cancer patients are limited.

Eligibility criteria

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 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. Hemodynamic instability with any of the following present:

   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

Where this trial is running

Houston, Texas

• The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Varshana Gurusamy, MD — M.D. Anderson Cancer Center
• Study coordinator: Varshana Gurusamy, MD

Conditions Cancer