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)

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.

Eligibility

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

Conditions2

Locations1 site

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