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

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).

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism; Acute Pulmonary Embolism
• Intervention / Treatment: Device: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • HonorHealth
  • California
    • Los Angeles, California, United States, 90404
      • UCLA Health
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University
  • Florida
    • Jacksonville, Florida, United States, 32216
      • HCA Memorial Hospital Jacksonville
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
    • Atlanta, Georgia, United States, 30303
      • Emory University at Grady Memorial Hospital
  • Illinois
    • Peoria, Illinois, United States, 61611
      • OSF Healthcare
  • Indiana
    • Indianapolis, Indiana, United States, 47405
      • Indiana University
    • Munster, Indiana, United States, 46321
      • Community Hospital
  • Louisiana
    • Jefferson, Louisiana, United States, 70121
      • Oshner Medical Center
  • Minnesota
    • Saint Cloud, Minnesota, United States, 56303
      • Centracare Heart and Vascular Center
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Rutgers University
  • New York
    • Bronx, New York, United States, 10461
      • Jacobi Medical Center
    • Buffalo, New York, United States, 14203
      • University of Buffalo
    • New York, New York, United States, 10032
      • Columbia University Medical Center/NYPH
  • Ohio
    • Columbus, Ohio, United States, 43221
      • Ohio State University Wexner Medical Center
    • Miamisburg, Ohio, United States, 45342
      • Kettering Health
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16550
      • UPMC Hamot
    • Montgomery, Pennsylvania, United States, 19403
      • Einstein Medical Center
    • Pittsburgh, Pennsylvania, United States, 15219
      • UPMC Pittsburgh
  • Tennessee
    • Knoxville, Tennessee, United States, 37934
      • Tennova Healthcare -Turkey Creek Medical Center
  • Texas
    • Dallas, Texas, United States, 75226
      • Baylor Heart and Vascular Hospital
    • Houston, Texas, United States, 77030
      • Memorial Hermann (University of Texas at Houston)
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA)	Change in Right Ventricle to Left Ventricle (RV/LV) ratio between baseline and 48 hours post-procedure assessed by Computed Tomography Angiography (CTA) and read by the study's core lab.	At 48 hours post-procedure
Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index 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 of: Clinical Deterioration; Pulmonary Vascular Injury; Cardiac Injury	Within 48 hours post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of Thrombolytics Within 48 Hours of the Procedure.	Use of thrombolytics within 48 hours of the procedure.	Within 48 hours of the procedure
Length of Stay in the Intensive Care Unit (ICU)/Hospital Within 30 Days Post-procedure.	Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure.	Within 30 days of the procedure
Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA).	Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by Computed Tomography Angiography (CTA) and read by the study's core lab. Modified Miller Index ranges from 0 - 16 (higher values mean higher thrombus burden) and a greater negative change is a better outcome.	At 48 hours post-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.	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.	Within 48 hours of the procedure
Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure.	Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure.	Within 30 days of the procedure
Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days.	Symptomatic PE recurrence within 30 days.	Within 30 days of the procedure

Collaborators and Investigators

• Sponsor: Angiodynamics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Actual): January 4, 2024
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: 2021-EVT-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes