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

NCT06697314 | Recruiting DMC FDA Device

• 1 other identifier: 2024-EVT-01
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Pulmonary Embolism (PE); Pulmonary Embolism

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (22)

• Reduction in clot burden

  48 hours

• Use of thrombolytics

  48 hours

• Change in Biomarkers

  48 hours

• Composite Major Adverse Events

  7 days

• Individual Major Adverse Events

  7 days

Other Outcomes (2)

• Cardiac MRI

  12 months

• Peak Oxygen Consumption

  12 months

Study Arms (1)

Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE

EXPERIMENTAL

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

Interventions

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

Also known as: thrombectomy, mechanial aspiration

Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Deprived of liberty or under court protection

Sponsors & Collaborators

• Angiodynamics, Inc.: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Poland

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Andrew Sharp

  University College Dublin, Rep. of Ireland

  PRINCIPAL INVESTIGATOR

• Erik Klok

  Leiden UMC, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitch Vanderpoll

CONTACT

+447790921819; mvanderpoll@angiodynamics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 20, 2024
• Study Start: June 15, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

PL (1)