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Tests treatment safety and results for Cancer
Official title 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)
ClinicalTrials.gov ID: NCT07298096
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with current or prior diagnosis of cancer
- Confirmed PE, based on computed tomographic pulmonary angiography (CTPA) imaging showing a filling defect in at least one main or proximal lobar...
- 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.
You likely can't join if
- Hemodynamic instability with any of the following present:
- Cardiac arrest
- Obstructive shock or persistent hypotension defined as systolic blood pressure (BP) \ 15 min, or requiring vasopressor or inotropic support to...
- Patients on ECMO
- History, imaging or hemodynamic findings consistent with chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease...
- Imaging evidence or other evidence that suggests, in the opinion of the Investigator, that catheter-based intervention is not appropriate for the...
See the full eligibility criteria
- Patients with current or prior diagnosis of cancer
- 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
- Patients must have adequate organ and marrow function as defined below:
- absolute neutrophil count ≥ 1,000/mcL
- Platelets ≥ 30,000/mcL
- As these procedures can be performed without the use of iodinated contrast, there are no specific requirements for renal function
- 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...
- All lines of prior systemic therapy are permissible. Standard concurrent chemotherapy, immunotherapy, or targeted therapy are permissible.
- Ability to understand and the willingness to sign a written informed consent document.
- Hemodynamic instability with any of the following present:
- Cardiac arrest
- Obstructive shock or persistent hypotension defined as systolic blood pressure (BP) \ 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 a. Including but not limited to large volume lung metastases...
- Allergy, hypersensitivity, or heparin induced thrombocytopenia (HIT)
- Severe active infection (e.g. sepsis) requiring treatment at time of enrollment
- Absolute neutrophil count \<1000 mm3 within 6 weeks of screening
- Life expectancy \<90 days
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.