Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
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
    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.

More Details

Status
Completed
Sponsor
Angiodynamics, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.