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Acute Pulmonary Embolism (PE)RECOVER-AVNCT06697314

Evaluating the Efficacy, Safety and Long Term Functional Outcomes of Percutaneous Mechanical Aspiration Thrombectomy for Treatment of Acute Pulmonary Embolism Using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System

A study testing AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in people with Acute Pulmonary Embolism (PE) and Pulmonary Embolism, run by Angiodynamics, Inc. at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To evaluate the efficacy, safety, and long-term functional outcomes of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for the treatment of acute pulmonary embolism. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
1 sitePoland
Study dates
15 Jun 2025to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Symptomatic, CTPA-proven acute PE with a maximum duration of symptoms of 14 days, showing a filling defect in at least one main or proximal lobar pulmonary artery
  • RV/LV diameter ratio ≥ 1.0 assessed by CTPA
  • Serum troponin levels above upper limit of normal as per hospital policy
  • ≥ 18 years of age
  • At least one of the following:
  • Electrocardiogram (ECG)-documented tachycardia with heart rate ≥ 100 BPM, not due to hypovolemia, arrhythmia or sepsis
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  • Systolic blood pressure ≤ 110mmHg for at least 15 minutes
  • Respiratory rate > 20 breaths per minuted. Oxygen saturation on pulse oximetry (SpO2) < 90% (or partial arterial oxygen pressure < 60 mmHg) at rest while breathing room air
  • Known history of heart failure
  • Willing and able to provide written informed consent prior to receiving study specific procedures.

Who cannot join

  • A contraindication to therapeutic anticoagulation
  • Any comorbid diagnosis consistent with a life expectancy of less than 1 year (e.g., stage 4 cancer)
  • Known serious, uncontrolled sensitivity to radiographic agents
  • Cardiac arrest within last 14 days without documented evidence of recovery of conscious level to Glasgow Coma Scale >12
  • Indication for ECMO
  • Pregnant or breastfeeding
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  • Participation in another investigational drug or device study that study may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.
  • Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow- up requirements, or that could impact the scientific integrity of the study.
  • History of congenital or acquired bleeding disorder predisposing to hemorrhagic state
  • Platelet count < 100,000/μL
  • Any advanced reperfusion therapy for pulmonary embolism within 30 days of the index procedure (e.g lysis, surgery, catheter intervention)
  • A known clot in transit
  • IVC filter
  • A do not resuscitate limitation at inclusion in the study
  • Deprived of liberty or under court protection

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mitch Vanderpoll contact

+447790921819

mvanderpoll@angiodynamics.com

Poland1 site, 1 recruiting

  • Poznan University of Medical Sciences

    Poznan

    Study Coordinator, +48 508 455 229, iwalaszkowska@ump.edu.pl

    Recruiting

Other trials in Poland

About this study

Official title: Prospective, Multicenter, Multi-national, Single Arm Trial Evaluating the Efficacy, Safety and Long Term Functional Outcomes of Percutaneous Mechanical Aspiration Thrombectomy for Treatment of Acute Pulmonary Embolism Using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System

To evaluate the efficacy, safety, and long-term functional outcomes of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for the treatment of acute pulmonary embolism.

Being tested
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
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 SystemDevice

    Also called thrombectomy, mechanial aspiration

    Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 for the treatment of acute pulmonary embolism

Study groups in NCT06697314
Study groupRoleWhat they receive
Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PEExperimentalProspective single-arm trial reporting the efficacy, safety, and long-term functional outcomes of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for the treatment of acute pulmonary embolism.
Receives: Device: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System

What is being measured

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

  1. Reduction in RV/LV ratio

    Reduction in RV/LV ratio between baseline and 48 hours post-procedure assessed by paired computed tomography pulmonary angiography (CTPA)

    Measured: 48 hours

  2. Incidence of Adverse Events [Safety and Tolerability]

    The primary safety endpoint is the incidence of adverse events by type and seriousness through 12 months. The number and proportion of subjects who experienced at least one adverse event will be summarized, and the 95% confidence interval of the proportion will be presented.

    Measured: 12 months

Secondary outcomes (22)

  1. Reduction in clot burden

    • Reduction in clot burden (measured by refined Modified Miller Index score) between baseline and 48 hours post-procedure assessed by paired CTPA

    Measured: 48 hours

  2. Use of thrombolytics

    Use of thrombolytics within 48 hours of the index procedure

    Measured: 48 hours

  3. Change in Biomarkers

    Change in troponin, BNP, and D-dimer from baseline to 48 hours post-procedure

    Measured: 48 hours

  4. Composite Major Adverse Events

    • Composite Major Adverse Events within 7 days of the index procedure
    1. PE-related death/deterioration:
    • Death
    • Cardiac Arrest
    • Institution of new vasopressors
    • ECMO
    • Mechanical ventilation
    1. Device-related death/deterioration:
    • Death
    • BARC 3a/3b/3c/-5 Major Bleeding
    • Clinical Deterioration
    • Pulmonary Vascular Injury
    • Peripheral Vascular Injury
    • Cardiac Injury
    • Stroke

    Measured: 7 days

  5. Individual Major Adverse Events

    Individual Major Adverse Events within 7 days of the index procedure

    • PE-related Death
    • PE-related Cardiac Arrest
    • PE-related institution of new vasopressors
    • PE-related ECMO
    • mechanical ventilation
    • device-related Death
    • device-related Major Bleeding
    • device-related Clinical Deterioration
    • device-related Pulmonary Vascular Injury
    • device-related Peripheral Vascular Injury
    • device-related Cardiac Injury
    • device-related Stroke

    Measured: 7 days

  6. Days in ITU

    Days in ITU post-index procedure admission

    Measured: 7 days

  7. All-cause mortality

    All-cause mortality within 30 days of the index procedure

    Measured: 30 days

  8. PE-related mortality

    • PE-related mortality within 30 days of the index procedure

    Measured: 30 days

  9. Device-related Serious Adverse Events

    Device-related Serious Adverse Events (SAEs) within 30 days of the index procedure

    Measured: 30 days

  10. Days In-patient

    Number of days in-patient on index procedure admission

    Measured: 30 days

  11. Hospital readmission

    Hospital readmission rate through 30 days

    Measured: 30 days

  12. Symptom burden exercise test

    6 minute walking test (MWT) at 30 days post-procedure

    Measured: 30 days

  13. Symptom burden classification

    New York Heart Association (NYHA) classification at 30 Days post-procedure

    Measured: 30 Days

  14. Functional outcome review

    PROMs at 30 Days post-procedure:

    • PROMIS Scale v1.2 - Global Health
    • PEmb-QoL
    • Post-VTE Functional Status Scale
    • PROMIS Short Form v2.0 - Pain Intensity 3a
    • PROMIS Short Form v1.0 - Dyspnea Severity 10a
    • PHQ-9
    • GAD-7

    Measured: 30 Days

  15. Symptomatic PE recurrence

    Symptomatic PE recurrence at 30 days post-procedure

    Measured: 30 days

  16. Symptom burden exercise test

    6 minute walking test (MWT) at 6 months post-procedure

    Measured: 6 months

  17. Symptom burden classification

    New York Heart Association (NYHA) classification at 6 months post-procedure

    Measured: 6 months

  18. PE-related readmission

    • PE-related hospital readmission rate through 12 months post-procedure

    Measured: 12 months

  19. Symptom burden exercise test

    6 minute walking test (MWT) at 12months post-procedure

    Measured: 12 months

  20. Symptom burden classification

    New York Heart Association (NYHA) classification at 12 months post-procedure

    Measured: 12 months

  21. Functional outcome review

    PROMs at 12 months post-procedure:

    • PROMIS Scale v1.2 - Global Health
    • PEmb-QoL
    • Post-VTE Functional Status Scale
    • PROMIS Short Form v2.0 - Pain Intensity 3a
    • PROMIS Short Form v1.0 - Dyspnea Severity 10a
    • PHQ-9
    • GAD-7

    Measured: 12 months

  22. CTEPH Diagnosis

    Diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) at 12 months post-procedure

    Measured: 12 months

Timeline

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

  1. First posted20 Nov 2024
  2. Study start15 Jun 2025
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

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
256 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06697314
Sponsor's protocol ID
2024-EVT-01
Acronym
RECOVER-AV
Status last verified
Sep 2025
First submitted
14 Nov 2024
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in people with Acute Pulmonary Embolism (PE) and Pulmonary Embolism, run by Angiodynamics, Inc. at 1 site in Poland.

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 10 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Mitch Vanderpoll (+447790921819, mvanderpoll@angiodynamics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in RV/LV ratio (time frame: 48 hours). 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 NCT06697314.

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 26 Sep 2025.

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