Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism (APEX-AV)
S
Sabah D. Butty, MD
Primary Investigator
Not Recruiting
18 years or above
All
Phase
N/A
122 participants needed
1 Location
Brief description of study
To evaluate the safety and effectiveness of percutaneous mechanical aspiration thrombectomy
using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE in a prospective trialwith acute intermediate-risk pulmonary embolism (PE).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Pulmonary Embolism, Acute Pulmonary Embolism
-
Age: 18 years or above
-
Gender: All
Inclusion Criteria:
- Signed and dated informed consent form.
- 18 years of age and older.
- Clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolismhan 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 guidelinesd/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 orgulants.
- 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 havejury 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 indexdure.
- History of severe or chronic pulmonary hypertension, uncompensated heart failure,hest irradiation, underlying lung disease that is oxygen dependent, Heparin-inducedhrombocytopenia (HIT) and/or chronic left heart disease with left ventricularjection 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 forhis procedure.
- Has life expectancy < 90 days.
- Dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO).
- Participation in another investigational study
Updated on
13 Dec 2024.
Study ID: 2021-EVT-01
