A Prospective Single Center, Single Arm, Single-institution Registry That Aims to Assess the Safe… (NCT07298096) | Clinical Trial Compass
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)
United States25 participantsStarted 2026-01-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with current or prior diagnosis of cancer. Histopathologic or radiologic imaging findings of primary or metastatic cancer are acceptable,
. Confirmed PE, based on computed tomographic pulmonary angiography (CTPA) imaging showing a filling defect in at least one main or proximal lobar pulmonary artery
. Classification of intermediate risk PE as defined by the institutional PERT algorithm
. Candidate for standard of care pulmonary thrombectomy
. Age greater than or equal to 18 years. The devices for mechanical thrombectomy are not suitably sized for pediatric patients.
. ECOG performance status less than or equal to 3
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year
. Patients must have adequate organ and marrow function as defined below:
. 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.
Exclusion criteria
. Hemodynamic instability with any of the following present:
. Cardiac arrest
. 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
. Patients on ECMO
. History, imaging or hemodynamic findings consistent with chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, that catheter-based intervention is not appropriate for the patient
. Allergy, hypersensitivity, or heparin induced thrombocytopenia (HIT)
. Severe active infection (e.g. sepsis) requiring treatment at time of enrollment