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Recruiting 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

No phase Interventional Acute Pulmonary Embolism (PE) Pulmonary Embolism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System.
Who it may be relevant to
Registry conditions: Acute Pulmonary Embolism (PE), Pulmonary Embolism. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Reduction in RV/LV ratio [Time frame: 48 hours]
  • Incidence of Adverse Events [Safety and Tolerability] [Time frame: 12 months]
Secondary outcome measures (12)
  • Reduction in clot burden [Time frame: 48 hours]
  • Use of thrombolytics [Time frame: 48 hours]
  • Change in Biomarkers [Time frame: 48 hours]
  • Composite Major Adverse Events [Time frame: 7 days]
  • Individual Major Adverse Events [Time frame: 7 days]
  • Days in ITU [Time frame: 7 days]
  • All-cause mortality [Time frame: 30 days]
  • PE-related mortality [Time frame: 30 days]
  • Device-related Serious Adverse Events [Time frame: 30 days]
  • Days In-patient [Time frame: 30 days]
  • Hospital readmission [Time frame: 30 days]
  • Symptom burden exercise test [Time frame: 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Poland · 1 center
  • Poznan University of Medical Sciences — Poznan

Identifiers

NCT: NCT06697314 · 2024-EVT-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗