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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with current or prior diagnosis of cancer. Histopathologic or radiologic imaging findings of primary or metastatic cancer are acceptable,
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 If ANC value is below 1,000/mcL, patient may be included if in the opinion of investigator, low ANC is due to ongoing chemotherapy and/or that it would not interfere with safe delivery of procedure or with the interpretation of study results.
   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. Patients being treated with emergency thrombectomy who are unable to consent prior to their procedure can be enrolled if the informed consent is provided and signed within 72 hours of the procedure.

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. Life expectancy \<90 days

Where it's running

• 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
• Email: vgurusamy@mdanderson.org
• Phone: 832-350-1456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.