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

AngioDynamics

Status

Completed

Conditions

Pulmonary Embolism

Acute Pulmonary Embolism

Treatments

Device: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE

Study type

Interventional

Funder types

Industry

Identifiers

NCT05318092

2021-EVT-01

Details and patient eligibility

About

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).

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).
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 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.
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