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Tests treatment safety and results for Pulmonary Embolism Acute
Official title Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness
ClinicalTrials.gov ID: NCT07280247
What this study is testing
- What it's testing
- The investigation is intended to evaluate the safety and effectiveness of the AlphaReturn Blood Management System when used in conjunction with the cleared AlphaVac MMA F1885 System for the treatment of acute pulmonary embolism.
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
- A potential subject will be included in the study if he/she meets all the following
- Provision of signed and dated informed consent form.
- Subject is 18 years of age and older.
- Subject presents clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days.
- Subject has a diagnosis of pulmonary embolism detected from computed tomography angiography (CTA).
You likely can't join if
- A potential subject will be excluded from the study if he/she meets any of the following exclusion criteria:
- people who are or may be pregnant as determined by a positive pregnancy test or who are breastfeeding.
- people who have any contraindication to systemic or therapeutic doses of heparin or anticoagulants.
- people who have used thrombolytics in the 30 days prior to the baseline CTA.
- people who have pulmonary hypertension with peak pulmonary artery pressure (PAP) \> 70 mmHg.
- people who have FiO2 requirement \> 44% or \> 6 LPM to keep oxygen saturations \> 90%.
See the full eligibility criteria
- A potential subject will be included in the study if he/she meets all the following
- Provision of signed and dated informed consent form.
- Subject is 18 years of age and older.
- Subject presents clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days.
- Subject has a diagnosis of pulmonary embolism detected from computed tomography angiography (CTA).
- Subject has a RV/LV ratio of 0.9 or higher.
- Subject has a systolic blood pressure (SBP) of 90mmHg or higher.
- Subject has a heart rate of 130 beats per minute (BPM) or less prior to the procedure.
- Subject is deemed medically eligible for treatment procedure(s) per institutional guidelines and/or clinical judgment.
- A potential subject will be excluded from the study if he/she meets any of the following exclusion criteria:
- people who are or may be pregnant as determined by a positive pregnancy test or who are breastfeeding.
- people who have any contraindication to systemic or therapeutic doses of heparin or anticoagulants.
- people who have used thrombolytics in the 30 days prior to the baseline CTA.
- people who have pulmonary hypertension with peak pulmonary artery pressure (PAP) \> 70 mmHg.
- people who have FiO2 requirement \> 44% or \> 6 LPM to keep oxygen saturations \> 90%.
- people with hematocrit \< 28% within 6 hours of index procedure.
- people with platelets count \< 100,000/μL.
- people with serum creatinine \> 1.8 mg/dL.
- people with International Normalized Ratio (INR) \> 3.
- people who have undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) \> 15.
- people with the presence of cancer requiring active chemotherapy.
- people with known bleeding diathesis or coagulation disorder.
- people who have had a cardiovascular or pulmonary surgery within the past 7 days of index procedure.
- people with a history of severe or chronic pulmonary hypertension, uncompensated heart failure, chest irradiation, underlying lung disease that is oxygen dependent, heparin-induced thrombocytopenia (HIT) and/or chronic...
- people with known anaphylactic reaction to radiographic contrast agents that cannot be pretreated.
- Subject requires vasopressor after fluids to keep pressure ≥ 90mmHg.
- people with left bundle branch block.
- people who have intracardiac lead in the right ventricle or atrium.
- Evidence such as imaging or other that suggest the subject is not appropriate for this procedure.
- people that have life expectancy \< 90 days, in the opinion of the investigator at the time of enrollment.
- people dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO).
- Participation in another investigational study.
The study team makes the final eligibility decision.
Where it's taking place
- Saint Cloud, Minnesota, United States
- Buffalo, New York, United States
- The Bronx, New York, United States
- Kettering, Ohio, United States
- Plano, Texas, United States
- San Antonio, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Saint Cloud, Minnesota, United States; Buffalo, New York, United States; The Bronx, New York, United States; Kettering, Ohio, United States; Plano, Texas, United States; San Antonio, 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.