RecruitingNot applicable

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at the safety of computer-assisted suction to remove blood clots from the lungs and how it affects quality of life. It is for adults with current or past cancer who have a medium-risk blood clot in the lungs.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older and have current or past cancer.
  • A special CT scan shows a blood clot in a main lung artery or a large branch. The hospital team rates the clot as medium risk.
  • You can receive lung clot removal as part of your usual care.
  • Your ability to do daily tasks meets the study’s limit: an ECOG score of 3 or less.
  • You have enough blood cells: at least 1,000 neutrophils, which fight infection, and 30,000 platelets, which help blood clot, per microliter. The study doctor may allow a lower neutrophil count in some cases.
  • Women who have not gone through menopause must have a negative pregnancy test. Others must meet the study’s rules for menopause or surgery that prevents pregnancy.
  • Past cancer drug treatments and ongoing standard cancer treatments are allowed. There is no specific kidney function requirement.
  • You can understand and sign the consent form. If emergency clot removal prevents consent beforehand, you may sign within 72 hours after the procedure.

Who can't join

  • Your heart has stopped, or your blood pressure is dangerously low or needs medicine to keep it up.
  • You use ECMO, a machine that supports your heart and lungs.
  • You have long-term blood clots in the lungs, with or without high blood pressure in the lung arteries.
  • The study doctor thinks treatment through a thin tube is not right for you. Reasons may include large amounts of cancer or tissue damage in the lungs.
  • You have an allergy or strong sensitivity, or a past drop in platelets caused by heparin, a blood thinner.
  • You have a severe active infection, such as sepsis, that needs treatment when you join.
  • You are expected to live less than 90 days.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

TX