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

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ClinicalTrials.gov Identifier: NCT05318092
Recruitment Status : Recruiting
First Posted : April 8, 2022
Last Update Posted : September 22, 2023
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.

Study Description
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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 acute intermediate-risk pulmonary embolism (PE).

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Acute Pulmonary Embolism Device: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism
Actual Study Start Date : October 19, 2022
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA. [ Time Frame: At 48 hours post-procedure ]
    Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.

  2. Rate of Major Adverse Events (MAEs) within the first 48 hours after the index procedure. [ Time Frame: At 48 hours post-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


Secondary Outcome Measures :
  1. Use of thrombolytics within 48 hours of the procedure. [ Time Frame: Within 48 hours of the procedure ]
    Use of thrombolytics within 48 hours of the procedure.

  2. Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure. [ Time Frame: Within 30 days of the procedure ]
    Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure.

  3. Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA. [ Time Frame: At 48 hours post-procedure ]
    Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA.

  4. 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. [ Time Frame: Within 48 hours of the 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.

  5. Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure. [ Time Frame: Within 30 days of the procedure ]
    Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure.

  6. Symptomatic PE recurrence within 30 days. [ Time Frame: Within 30 days of the procedure ]
    Symptomatic PE recurrence within 30 days.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05318092


Contacts
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Contact: Elizabeth Manning 339-237-2765 liz.manning@angiodynamics.com

Locations
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Sponsors and Collaborators
Angiodynamics, Inc.
More Information
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Responsible Party: Angiodynamics, Inc.
ClinicalTrials.gov Identifier: NCT05318092    
Other Study ID Numbers: 2021-EVT-01
First Posted: April 8, 2022    Key Record Dates
Last Update Posted: September 22, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases