Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
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

Led by Angiodynamics, Inc. · Updated on 2025-09-26

256

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Symptomatic, CTPA-proven acute pulmonary embolism with symptoms lasting no more than 14 days and a filling defect in at least one main or proximal lobar pulmonary artery
  • Right ventricle to left ventricle diameter ratio of 1.0 or greater as assessed by CTPA
  • Serum troponin levels above the upper limit of normal according to hospital standards
  • 18 years of age or older
  • At least one of the following: ECG showing tachycardia with heart rate 100 BPM or greater not caused by hypovolemia, arrhythmia, or sepsis; systolic blood pressure 110 mmHg or less for at least 15 minutes; respiratory rate over 20 breaths per minute; oxygen saturation below 90% on room air at rest; or known history of heart failure
  • Willing and able to provide written informed consent before study procedures
Not Eligible

You will not qualify if you...

  • Contraindication to therapeutic anticoagulation
  • Any comorbid condition with life expectancy less than 1 year (e.g., stage 4 cancer)
  • Known serious uncontrolled sensitivity to radiographic agents
  • Cardiac arrest within last 14 days without recovery to Glasgow Coma Scale over 12
  • Need for extracorporeal membrane oxygenation (ECMO)
  • Pregnant or breastfeeding
  • Participation in another investigational drug or device study that could affect study results
  • Medical, social, or psychological conditions limiting consent ability or compliance
  • History of congenital or acquired bleeding disorders that increase bleeding risk
  • Platelet count below 100,000/μL
  • Advanced reperfusion therapy for pulmonary embolism within 30 days prior to study
  • Presence of a clot in transit
  • Presence of an inferior vena cava (IVC) filter
  • Do not resuscitate order at study inclusion
  • Deprived of liberty or under court protection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Poznan University of Medical Sciences

Poznan, Poland

Actively Recruiting

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Research Team

M

Mitch Vanderpoll

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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