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 (RECOVER-AV)

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Embolism; Acute Pulmonary Embolism (PE)
• Intervention / Treatment: Device: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mitch Vanderpoll; Phone Number: +447790921819; Email: mvanderpoll@angiodynamics.com

Study Locations

• Poland
  • Poznan, Poland
    • Recruiting
    • Poznan University of Medical Sciences
    • Contact: Study Coordinator; Phone Number: +48 508 455 229; Email: iwalaszkowska@ump.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

  1. Electrocardiogram (ECG)-documented tachycardia with heart rate ≥ 100 BPM, not due to hypovolemia, arrhythmia or sepsis
  2. Systolic blood pressure ≤ 110mmHg for at least 15 minutes
  3. 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
  4. 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE; Prospective 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.	Device: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System; Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 for the treatment of acute pulmonary embolism; Other Names: thrombectomy; mechanial aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	48 hours
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 hours
Use of thrombolytics	Use of thrombolytics within 48 hours of the index procedure	48 hours
Change in Biomarkers	Change in troponin, BNP, and D-dimer from baseline to 48 hours post-procedure	48 hours
Composite Major Adverse Events	Composite Major Adverse Events within 7 days of the index procedure1) PE-related death/deterioration:; Death; Cardiac Arrest; Institution of new vasopressors; ECMO; Mechanical ventilation2) Device-related death/deterioration:; Death; BARC 3a/3b/3c/-5 Major Bleeding; Clinical Deterioration; Pulmonary Vascular Injury; Peripheral Vascular Injury; Cardiac Injury; Stroke	7 days
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	7 days
Days in ITU	Days in ITU post-index procedure admission	7 days
All-cause mortality	All-cause mortality within 30 days of the index procedure	30 days
PE-related mortality	• PE-related mortality within 30 days of the index procedure	30 days
Device-related Serious Adverse Events	Device-related Serious Adverse Events (SAEs) within 30 days of the index procedure	30 days
Days In-patient	Number of days in-patient on index procedure admission	30 days
Hospital readmission	Hospital readmission rate through 30 days	30 days
Symptom burden exercise test	6 minute walking test (MWT) at 30 days post-procedure	30 days
Symptom burden classification	New York Heart Association (NYHA) classification at 30 Days post-procedure	30 Days
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	30 Days
Symptomatic PE recurrence	Symptomatic PE recurrence at 30 days post-procedure	30 days
Symptom burden exercise test	6 minute walking test (MWT) at 6 months post-procedure	6 months
Symptom burden classification	New York Heart Association (NYHA) classification at 6 months post-procedure	6 months
PE-related readmission	- PE-related hospital readmission rate through 12 months post-procedure	12 months
Symptom burden exercise test	6 minute walking test (MWT) at 12months post-procedure	12 months
Symptom burden classification	New York Heart Association (NYHA) classification at 12 months post-procedure	12 months
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	12 months
CTEPH Diagnosis	Diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) at 12 months post-procedure	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac MRI	• 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	12 months
Peak Oxygen Consumption	• Peak Oxygen consumption (for up to 100 patients): PVO2 measured during cardiopulmonary exercise test at 12 months post-procedure	12 months

Collaborators and Investigators

• Sponsor: Angiodynamics, Inc.
• Investigators: Principal Investigator: Andrew Sharp, University College Dublin, Rep. of Ireland; Principal Investigator: Erik Klok, Leiden UMC, The Netherlands

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism; Surgical Procedures, Operative; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Thrombectomy
• Other Study ID Numbers: 2024-EVT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes