Status:
COMPLETED
Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism
Lead Sponsor:
Angiodynamics, Inc.
Conditions:
Pulmonary Embolism
Acute Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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).
- Right Ventricle to Left Ventricle (RV/LV) ratio of 0.9 or higher.
- Systolic blood pressure (SBP) of 90 mmHg 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
- 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.
- Fraction of inspired oxygen (FiO2) requirement \>40% or \>6 liters per minute (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 ≥ 90 mmHg.
- 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
Key Trial Info
Start Date :
October 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2024
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT05318092
Start Date
October 19 2022
End Date
January 4 2024
Last Update
July 19 2024
Active Locations (25)
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1
HonorHealth
Scottsdale, Arizona, United States, 85258
2
UCLA Health
Los Angeles, California, United States, 90404
3
Yale University
New Haven, Connecticut, United States, 06519
4
HCA Memorial Hospital Jacksonville
Jacksonville, Florida, United States, 32216