Vibrato Aspiration System for clot removal in acute pulmonary embolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm, multicenter study evaluating the safety and effectiveness of the Vibrato™ Aspiration System for aspiration mechanical thrombectomy in acute PE. The device uses vibration to aid thrombus removal during suction with the aim of improving clot clearance, reducing procedure time, and minimizing vascular injury without requiring extra capital equipment. Enrolled participants are adults up to 75 years old with confirmed proximal PE and specific hemodynamic criteria, undergoing the thrombectomy procedure. The trial focuses on safety outcomes and the device’s ability to achieve clot removal as one-arm feasibility data. Follow-up and monitoring are conducted per the Clinical Investigation Plan at participating centers.

Why it matters

Who can join: the full rules

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

Where it's running

• Krakowski Szpital Specjalistyczny im. św. Jana Pawła II
  Krakow, Lesser Poland Voivodeship, Poland Recruiting
• Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu Uniwersytecki Szpital Kliniczny
  Poznan, Greater Poland Voivodeship, Poland Not yet recruiting

Study contacts

• Study coordinator: Shawn M Patterson
• Email: spatterson@egrethealthcareventure.com
• Phone: 7164323545

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.