Pulmonary EmbolismAPEX-AVNCT05318092

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

A study testing AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE in people with Pulmonary Embolism and Acute Pulmonary Embolism, run by Angiodynamics, Inc. at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Embolism, Acute Pulmonary Embolism
What is being tested?: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 122 participants
Where: 25 sitesUnited States
Study dates: 19 Oct 2022to 4 Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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%

Show all 23Show fewer

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

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

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

Other trials in United States

About this study

Conditions: Pulmonary Embolism, Acute Pulmonary Embolism
Being tested: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE
Medical subject headings: Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PEDevice
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.

Study groups in NCT05318092
Study group	Role	What they receive
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE	Experimental	Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for the treatment of acute pulmonary embolism Receives: Device: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: Within 48 hours post-procedure

Secondary outcomes (6)

Use of Thrombolytics Within 48 Hours of the Procedure.
Use of thrombolytics within 48 hours of the procedure.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 30 days of the procedure
Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days.
Symptomatic PE recurrence within 30 days.
Measured: Within 30 days of the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 20224 Jan 2024

First posted8 Apr 2022
Study start19 Oct 2022
Primary completion4 Jan 2024
Study completion4 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
More trials run by Angiodynamics, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05318092
Sponsor's protocol ID: 2021-EVT-01
Acronym: APEX-AV
Status last verified: Jul 2024
First submitted: 24 Mar 2022
Last updated: 19 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)

All Pulmonary Embolism trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism
ClinicalTrials.gov ID: NCT05318092
Acronym / sponsor ID: APEX-AV / 2021-EVT-01
Conditions: Pulmonary Embolism, Acute Pulmonary Embolism
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Angiodynamics, Inc.Industry (pharma, biotech, devices)
Study start: 19 Oct 2022 (actual)
Primary completion: 4 Jan 2024 (actual)
Study completion: 4 Jan 2024 (actual)
First posted: 8 Apr 2022 (actual)
Results: Posted 19 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE	Experimental	Device: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PESingle Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for the treatment of acute pulmonary embolism

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (23 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PEThe AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE has five main components, a flexible cannula (F1885), sheath, tapered obturator, aspirator handle, and waste bag.	Device	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE

Primary outcome

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.
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

6 secondary outcomes

Use of Thrombolytics Within 48 Hours of the Procedure.
Time frame: 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
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
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 Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure.
Time frame: Within 30 days of the procedure
Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days.
Time frame: Within 30 days of the procedure

Results and safety

Results posted to the registry on 19 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System	122	118

Primary outcome: 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. Mean (Standard Deviation). Unit: ratio

Measure	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System n = 119
Value	-0.45 (0.27)

Population analysed: Modified 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, who did not receive thrombolytics during the index procedure.

Primary outcome: Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index Procedure.

Time frame: Within 48 hours post-procedure. Count of participants. Unit: Participants

Measure	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System n = 122
Subjects experiencing a MAE	5
Subjects not experiencing a MAE	117

Population analysed: 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.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days (+/- 7 days) post-procedure. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System	18 of 122 (14.8%)	9 of 122 (7.4%)	0 of 122

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pulmonary Embolism

RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE in people with Pulmonary Embolism and Acute Pulmonary Embolism, run by Angiodynamics, Inc. at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05318092.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.