Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism

Study Overview
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Brief Summary
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To evaluate the safety and effectiveness of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE).

Official Title
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Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism

Conditions
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Pulmonary Embolism, Acute Pulmonary Embolism

Intervention / Treatment
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* Device: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent form. 18 years of age and older. Clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days. Diagnosis of pulmonary embolism detected from computed tomography angiography (CTA). RV/LV ratio of 0.9 or higher. Systolic blood pressure (SBP) of 90mmHg or higher Heart rate of 130 beats per minute (BPM) or less prior to the procedure. Deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment. Exclusion Criteria: Excluded from the study if he/she meets any of the following exclusion criteria May be pregnant as determined by a positive pregnancy test or who are breastfeeding. Has any contraindication to systemic or therapeutic doses of heparin or anticoagulants. Has used thrombolytics (tPA) in the past 30 days of baseline CTA. Has pulmonary hypertension with peak pulmonary artery pressure (PAP) > 70 mmHg. FiO2 requirement >40% or >6 LPM to keep oxygen saturations >90% Hematocrit <28% within 6 hours of the index procedure. Platelets count < 100,000/µL. Serum creatinine >1.8 mg/dL. International Normalized Ratio (INR) > 3 Has undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) > 15. Presence of cancer requiring active chemotherapy. Known bleeding diathesis or coagulation disorder. Has had a cardiovascular or pulmonary surgery within the past 7 days of index procedure. 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 left heart disease with left ventricular ejection fraction ≤ 30%. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated. Requires Vasopressor after fluids to keep pressure ≥ 90mmHg. With left bundle branch block. Has intracardiac lead in the right ventricle or atrium. Evidence such as imaging or other that suggests the subject is not appropriate for this procedure. Has life expectancy < 90 days. Dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO). Participation in another investigational study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE<br>Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for the treatment of acute pulmonary embolism | Device: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE<br>* The AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE has five main components, a flexible cannula (F1885), sheath, tapered obturator, aspirator handle, and waste bag.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA. | Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA. | At 48 hours post-procedure | 
| Rate of Major Adverse Events (MAEs) within the first 48 hours after the index procedure. | Rate of Major Adverse Events (MAEs) within the first 48 hours after the index procedure, defined as: Device-related death Major bleeding Device-related SAEs which includes: Clinical Deterioration Pulmonary Vascular Injury Cardiac Injury | At 48 hours post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of thrombolytics within 48 hours of the procedure. | Use of thrombolytics within 48 hours of the procedure. | Within 48 hours of the procedure | 
| Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure. | Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure. | Within 30 days of the procedure | 
| Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA. | Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA. | At 48 hours post-procedure | 
| Rate of device related complications including clinical deterioration, cardiac injury, pulmonary vascular injury, major bleeding, and device-related death within 48 hours of the index procedure. | Rate of device related complications including clinical deterioration, cardiac injury, pulmonary vascular injury, major bleeding, and device-related death within 48 hours of the index procedure. | Within 48 hours of the procedure | 
| Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure. | Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure. | Within 30 days of the procedure | 
| Symptomatic PE recurrence within 30 days. | Symptomatic PE recurrence within 30 days. | Within 30 days of the procedure |