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NCT Number: NCT06697314

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.

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Key information

Conditions

Acute Pulmonary Embolism (PE) Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System

Device

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

Other names: thrombectomy, mechanial aspiration

Primary outcomes

  1. Reduction in RV/LV ratio

    Time frame: 48 hours

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

  2. Incidence of Adverse Events [Safety and Tolerability]

    Time frame: 12 months

    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.

Secondary outcomes

  1. Reduction in clot burden

    Time frame: 48 hours

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

  2. Use of thrombolytics

    Time frame: 48 hours

    Use of thrombolytics within 48 hours of the index procedure

  3. Change in Biomarkers

    Time frame: 48 hours

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

  4. Composite Major Adverse Events

    Time frame: 7 days

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

  5. Individual Major Adverse Events

    Time frame: 7 days

    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

  6. Days in ITU

    Time frame: 7 days

    Days in ITU post-index procedure admission

  7. All-cause mortality

    Time frame: 30 days

    All-cause mortality within 30 days of the index procedure

  8. PE-related mortality

    Time frame: 30 days

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

  9. Device-related Serious Adverse Events

    Time frame: 30 days

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

  10. Days In-patient

    Time frame: 30 days

    Number of days in-patient on index procedure admission

  11. Hospital readmission

    Time frame: 30 days

    Hospital readmission rate through 30 days

  12. Symptom burden exercise test

    Time frame: 30 days

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

  13. Symptom burden classification

    Time frame: 30 Days

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

  14. Functional outcome review

    Time frame: 30 Days

    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

  15. Symptomatic PE recurrence

    Time frame: 30 days

    Symptomatic PE recurrence at 30 days post-procedure

  16. Symptom burden exercise test

    Time frame: 6 months

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

  17. Symptom burden classification

    Time frame: 6 months

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

  18. PE-related readmission

    Time frame: 12 months

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

  19. Symptom burden exercise test

    Time frame: 12 months

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

  20. Symptom burden classification

    Time frame: 12 months

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

  21. Functional outcome review

    Time frame: 12 months

    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

  22. CTEPH Diagnosis

    Time frame: 12 months

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

Other outcomes

  1. Cardiac MRI

    Time frame: 12 months

    • Cardiac MRI at 12-months post-procedure (for up to 100 patients) to assess:
    • RA/RV dimension and function
    • Signs of RV fibrosis
    • Pulmonary parenchymal function and abnormalities
    • Pulmonary vascular structure
    • Tricuspid regurgitation severity
    • Ventricular Septal motion characteristics

  2. Peak Oxygen Consumption

    Time frame: 12 months

    • Peak Oxygen consumption (for up to 100 patients): PVO2 measured during cardiopulmonary exercise test at 12 months post-procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Mitch Vanderpoll

CONTACT

[email protected]

+447790921819

Sponsors and collaborators

Lead sponsor

Angiodynamics, Inc.

Industry

Registry information

Official study 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

Acronym: RECOVER-AV

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 20, 2024
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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