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CompletedNCT05318092APEX-AVUpdated Jul 19, 2024Results posted

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

An interventional study of AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE in Pulmonary Embolism and Acute Pulmonary Embolism, sponsored by Angiodynamics, Inc.. Completed at 25 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-19.

Sponsored by Angiodynamics, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
122
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Pulmonary Embolism
  • Acute Pulmonary Embolism
03

In context

Pulmonary Embolism

739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.

This study's enrollment of 122 is below the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

Angiodynamics, Inc. is the lead sponsor of 21 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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).
  • 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
122 participants (actual)

Study arms

  • 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

Interventions

  • DeviceAlphaVac 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At 48 hours post-procedure

  2. 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

    Time frame: Within 48 hours post-procedure

Secondary outcomes

  1. Use of Thrombolytics Within 48 Hours of the Procedure.

    Use of thrombolytics within 48 hours of the procedure.

    Time frame: Within 48 hours of the procedure

  2. 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.

    Time frame: Within 30 days of the procedure

  3. 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.

    Time frame: At 48 hours post-procedure

  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.

    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

  5. 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.

    Time frame: Within 30 days of the procedure

  6. Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days.

    Symptomatic PE recurrence within 30 days.

    Time frame: Within 30 days of the procedure

07

Results

Posted Jul 19, 2024

Participant flow

Participant flow — Overall Study
MilestoneAlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Started122
Completed118
Not completed4
Withdrew: Lost to follow-up3
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryChange 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.

Time frame:
At 48 hours post-procedure
Reported as:
Mean · ratio
Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA)
ratioAlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA)-0.45 ± 0.27
PrimaryRate 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

Time frame:
Within 48 hours post-procedure
Reported as:
Count of participants · Participants
Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index Procedure.
ParticipantsAlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Subjects experiencing a MAE5
Subjects not experiencing a MAE117
SecondaryUse of Thrombolytics Within 48 Hours of the Procedure.

Use of thrombolytics within 48 hours of the procedure.

Time frame:
Within 48 hours of the procedure
Reported as:
Count of participants · Participants
Use of Thrombolytics Within 48 Hours of the Procedure.
ParticipantsAlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Use of Thrombolytics Within 48 Hours of the Procedure.0
SecondaryLength 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.

Time frame:
Within 30 days of the procedure
Reported as:
Mean · days
Length of Stay in the Intensive Care Unit (ICU)/Hospital Within 30 Days Post-procedure.
daysAlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Length of Stay in ICU1.4 ± 1.7
Length of Stay in Hospital5.2 ± 3.3
SecondaryChange 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.

Time frame:
At 48 hours post-procedure
Reported as:
Mean · score on a scale
Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA).
score on a scaleAlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA).-5.6 ± 4.3
SecondaryRate 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.

Time frame:
Within 48 hours of the procedure
Reported as:
Count of participants · Participants
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.
ParticipantsAlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Device-related clinical deterioration — Subjects with event1
Device-related clinical deterioration — Subjects without event121
Device-related pulmonary vascular injury — Subjects with event1
Device-related pulmonary vascular injury — Subjects without event121
Device-related cardiac injury — Subjects with event1
Device-related cardiac injury — Subjects without event121
Major bleeding — Subjects with event5
Major bleeding — Subjects without event117
Device-related death — Subjects with event0
Device-related death — Subjects without event122
SecondaryRate 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.

Time frame:
Within 30 days of the procedure
Reported as:
Count of participants · Participants
Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure.
ParticipantsAlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Device-related SAEs — Subjects with event4
Device-related SAEs — Subjects without event118
Death for any cause — Subjects with event0
Death for any cause — Subjects without event122
SecondarySymptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days.

Symptomatic PE recurrence within 30 days.

Time frame:
Within 30 days of the procedure
Reported as:
Count of participants · Participants
Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days.
ParticipantsAlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days.1

Adverse events

Collected over 30 days (+/- 7 days) post-procedure. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System0/122 (0%)18/122 (14.8%)9/122 (7.4%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventAlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
HaemorrhageVascular disorders5/122
DyspnoeaRespiratory, thoracic and mediastinal disorders2/122
Acute myocardial infarctionCardiac disorders1/122
ArrhythmiaCardiac disorders1/122
Cardiogenic shockCardiac disorders1/122
Supraventricular tachycardiaCardiac disorders1/122
Non-cardiac chest painGeneral disorders1/122
CholelithiasisHepatobiliary disorders1/122
Vascular access site painInjury, poisoning and procedural complications1/122
Staphylococcus test positiveInvestigations1/122
Most frequent other events
Most frequent other events
EventAlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Deep vein thrombosisVascular disorders9/122

Baseline characteristics

As Treated Population - all subjects who met the inclusion/exclusion criteria of the study and in whom the AlphaVac MMA F1885 cannula was placed within the jugular or one of the common femoral veins.

Age, Continuous
Age, Continuous(years)AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Mean61.9 ± 14.6
Sex: Female, Male
Sex: Female, Male(Participants)AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Female68
Male54
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Hispanic or Latino5
Not Hispanic or Latino113
Unknown or Not Reported4
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American34
White84
More than one race0
Unknown or Not Reported4
Region of Enrollment
Region of Enrollment(participants)AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
United States122
Baseline Right Ventricle to Left Ventricle (RV/LV) Ratio
Baseline Right Ventricle to Left Ventricle (RV/LV) Ratio(ratio)AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Mean1.5 ± 0.31
08

Study locations

25 sites
  • HonorHealth
    Scottsdale, Arizona 85258, United States
  • UCLA Health
    Los Angeles, California 90404, United States
  • Yale University
    New Haven, Connecticut 06519, United States
  • HCA Memorial Hospital Jacksonville
    Jacksonville, Florida 32216, United States
  • Emory University at Grady Memorial Hospital
    Atlanta, Georgia 30303, United States
  • Piedmont Heart Institute
    Atlanta, Georgia 30309, United States
  • OSF Healthcare
    Peoria, Illinois 61611, United States
  • Indiana University
    Indianapolis, Indiana 47405, United States
  • Community Hospital
    Munster, Indiana 46321, United States
  • Oshner Medical Center
    Jefferson, Louisiana 70121, United States
  • CentraCare Heart and Vascular Center
    Saint Cloud, Minnesota 56303, United States
  • Rutgers University
    Newark, New Jersey 07103, United States
  • Jacobi Medical Center
    Bronx, New York 10461, United States
  • University of Buffalo
    Buffalo, New York 14203, United States
  • Columbia University Medical Center/NYPH
    New York, New York 10032, United States
  • Ohio State University Wexner Medical Center
    Columbus, Ohio 43221, United States
  • Kettering Health
    Miamisburg, Ohio 45342, United States
  • UPMC Hamot
    Erie, Pennsylvania 16550, United States
  • Einstein Medical Center
    Montgomery, Pennsylvania 19403, United States
  • UPMC Pittsburgh
    Pittsburgh, Pennsylvania 15219, United States
  • Tennova Healthcare -Turkey Creek Medical Center
    Knoxville, Tennessee 37934, United States
  • Baylor Heart and Vascular Hospital
    Dallas, Texas 75226, United States
  • Memorial Hermann (University of Texas at Houston)
    Houston, Texas 77030, United States
  • Methodist Hospital
    San Antonio, Texas 78229, United States
  • Aurora Health Care
    Milwaukee, Wisconsin 53215, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 7, 2023

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05318092
Lead sponsor
Angiodynamics, Inc.
Responsible party
Sponsor
First posted
Apr 8, 2022
Start date
Oct 19, 2022
Primary completion
Jan 4, 2024
Completion
Jan 4, 2024
Results posted
Jul 19, 2024
Last update
Jul 19, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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