Mechanical Thrombectomy: Mechanical Thrombectomy for the treatment of Acute Pulmonary Embolism
Study summary
The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vibrato™ Aspiration System for aspiration mechanical thrombectomy in the treatment of acute PE. This is the First in Man clinical study.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
Subjects must meet all following general inclusion criteria:
1. Age ≥ 18 and ≤ 75 years.
2. Clinical signs, symptoms, and presentation consistent with acute PE;
3. PE symptom duration ≤ 14 days;
4. CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)
5. RV/LV ratio of ≥ 0.9 on CTA as assessed by investigator (site determined).
6. Systolic blood pressure ≥ 90 mmHg;
7. Stable heart rate \< 130 BPM prior to procedure;
8. Patient is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment
9. Informed Consent Form signed
10. Subject is willing and able to comply with all Clinical Investigation Plan required follow-up visit
Exclusion Criteria:
Subjects must not meet any of the following general exclusion criteria:
1. Thrombolytic use within 30 days of baseline CT angiogram
2. Pulmonary hypertension with peak pulmonary artery pressure \> 70 mmHg by right heart catheterization (site determined)
3. Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg;
4. FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90%;
5. Hematocrit \< 28%;
6. Platelets \< 100,000/ML;
7. Serum creatinine \> 1.8 mg/dL;
8. International normalized ratio (INR) \> 3;
9. Major trauma injury severity score (ISS) \> 15 within the past 14 days
10. Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months, Pacemaker or Implantable Cardioverter Defibrillators;
11. Cardiovascular or pulmonary surgery within last 7 days;
12. Actively progressing cancer requiring chemotherapy
13. Known bleeding diathesis or coagulation disorder;
14. Left bundle branch block;
15. History of severe or chronic pulmonary arterial hypertension;
16. History of chronic left heart disease with left ventricular ejection fraction ≤ 30%;
17. History of uncompensated heart failure;
18. History of underlying lung disease that is oxygen dependent;
19. History of chest irradiation;
20. History of heparin-induced thrombocytopenia (HIT);
21. Patients who are under intubation
22. Any contraindication to systemic or therapeutic doses of heparin or anticoagulants;
23. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated;
24. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention;
25. Life expectancy of \< 90 days, as determined by Investigator;
26. Female who is pregnant or nursing;
27. Current participation in another investigational drug or device treatment study
28. History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days
29. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
Primary outcome measure(s)
Safety Endpoint: Major Adverse Events — 48 hours Major Adverse Events, a composite of:
* Device-related death within 48 hours
* Major bleeding within 48 hours
* Device-related AEs within 48 hours, including:
* Clinical deterioration
* Pulmonary vascular injury
* Cardiac injury
Efficacy Endpoint: Reduction in RV/LV Ratio — 48 hours Reduction in RV/LV ratio from baseline to 48 hours or discharge by CT angiography
Trial sites (2)
Facility
City
Region
Status
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu Uniwersytecki Szpital Kliniczny
Poznan
Greater Poland Voivodeship
Not Yet Recruiting
Krakowski Szpital Specjalistyczny im. św. Jana Pawła II
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.