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

July 18, 2024 updated by: Angiodynamics, Inc.
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Time Frame: At 48 hours post-procedure
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.
Time Frame: Within 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 of:

  • Clinical Deterioration
  • Pulmonary Vascular Injury
  • Cardiac Injury
Within 48 hours post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Within 48 hours of the procedure
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.
Within 30 days of the procedure
Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA).
Time Frame: At 48 hours post-procedure
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.
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.
Within 48 hours of the procedure
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.
Within 30 days of the procedure
Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days.
Time Frame: Within 30 days of the procedure
Symptomatic PE recurrence within 30 days.
Within 30 days of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Angiodynamics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings