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Pulmonary Embolism AcuteNCT07685522

Vibrato Aspiration System - Simple, Intuitive Approach to Clot Removal in Acute Pulmonary Embolism - a Safety & Feasibility Study

A study testing Mechanical Thrombectomy in people with Pulmonary Embolism Acute, run by Vicora, Inc. at 2 sites in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pulmonary Embolism Acute
What is being tested?
Mechanical Thrombectomy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesPoland
Study dates
21 Aug 2026to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all following general inclusion criteria:
  • Age ≥ 18 and ≤ 75 years.
  • Clinical signs, symptoms, and presentation consistent with acute PE;
  • PE symptom duration ≤ 14 days;
  • CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)
  • RV/LV ratio of ≥ 0.9 on CTA as assessed by investigator (site determined).
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  • Systolic blood pressure ≥ 90 mmHg;
  • Stable heart rate < 130 BPM prior to procedure;
  • Patient is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment
  • Informed Consent Form signed
  • Subject is willing and able to comply with all Clinical Investigation Plan required follow-up visit

Who cannot join

  • Subjects must not meet any of the following general exclusion criteria:
  • Thrombolytic use within 30 days of baseline CT angiogram
  • Pulmonary hypertension with peak pulmonary artery pressure > 70 mmHg by right heart catheterization (site determined)
  • Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg;
  • FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%;
  • Hematocrit < 28%;
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  • Platelets < 100,000/ML;
  • Serum creatinine > 1.8 mg/dL;
  • International normalized ratio (INR) > 3;
  • Major trauma injury severity score (ISS) > 15 within the past 14 days
  • Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months, Pacemaker or Implantable Cardioverter Defibrillators;
  • Cardiovascular or pulmonary surgery within last 7 days;
  • Actively progressing cancer requiring chemotherapy
  • Known bleeding diathesis or coagulation disorder;
  • Left bundle branch block;
  • History of severe or chronic pulmonary arterial hypertension;
  • History of chronic left heart disease with left ventricular ejection fraction ≤ 30%;
  • History of uncompensated heart failure;
  • History of underlying lung disease that is oxygen dependent;
  • History of chest irradiation;
  • History of heparin-induced thrombocytopenia (HIT);
  • Patients who are under intubation
  • Any contraindication to systemic or therapeutic doses of heparin or anticoagulants;
  • Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated;
  • Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention;
  • Life expectancy of < 90 days, as determined by Investigator;
  • Female who is pregnant or nursing;
  • Current participation in another investigational drug or device treatment study
  • History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days
  • Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shawn M Patterson contact

7164323545

spatterson@egrethealthcareventure.com

Erin M Garcia contact

716-863-2552

egarcia@egrethealthcareventures.com

Poland2 sites, 2 recruiting

  • Krakowski Szpital Specjalistyczny im. św. Jana Pawła II

    Krakow, Lesser Poland Voivodeship, 31-202

    Grzegorz Kopeć, Professor, MD, PhD

    Recruiting

  • Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu Uniwersytecki Szpital Kliniczny

    Poznan, Greater Poland Voivodeship, 61-848

    Aleksander Araszkiewicz, Professor, MD, PhD

    Not yet recruiting

Other trials in Poland

About this study

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.

Read the detailed description

The study objective is to evaluate the safety and effectiveness of the Vibrato™ Aspiration System Aspiration System (hereafter referred to as Vibrato™ Aspiration System) for aspiration mechanical thrombectomy in the treatment of acute PE.

The Vibrato™ Aspiration System is a vibration-assisted aspiration thrombectomy device including attributes designed to improve trackability, maintain a low-profile configuration, and operate without capital equipment. In addition, the Vibrato™ Aspiration System features a novel vibrating distal tip designed to enhance thrombus removal during aspiration while minimizing vascular injury. The vibrating mechanism may reduce procedure times, improve clot removal efficiency, and decrease the need for adjunctive interventions.

Being tested
Mechanical Thrombectomy
Keywords
Pulmonary Embolism, Clot, DVT
Medical subject headings
Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mechanical ThrombectomyDevice

    Mechanical Thrombectomy for the treatment of Acute Pulmonary Embolism

Study groups in NCT07685522
Study groupRoleWhat they receive
Single arm studyExperimentalVibrato™ Aspiration System for aspiration mechanical thrombectomy in the treatment of acute pulmonary embolism.
Receives: Device: Mechanical Thrombectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Endpoint: Major Adverse Events

    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

    Measured: 48 hours

  2. Efficacy Endpoint: Reduction in RV/LV Ratio

    Reduction in RV/LV ratio from baseline to 48 hours or discharge by CT angiography

    Measured: 48 hours

Secondary outcomes (19)

  1. Safety Endpoint: Device-Related Death

    Device-related death within 48 hours

    Measured: 48 hours

  2. Safety Endpoint: Major Bleeding

    Major bleeding within 48 hours

    Measured: 48 Hours

  3. Safety Endpoint: Device-Related Clinical Deterioration

    Device-related clinical deterioration within 48 hours

    Measured: 48 Hours

  4. Safety Endpoint: Device-Related Pulmonary Vascular Injury

    Device-related pulmonary vascular injury within 48 hours

    Measured: 48 Hours

  5. Safety Endpoint: Cardiac Injury

    Cardiac injury within 48 hours

    Measured: 48 Hours

  6. Safety Endpoint: Any-Cause Mortality

    Any-cause mortality within 30 days

    Measured: 30 Days

  7. Safety Endpoint: Device-Related Serious Adverse Event

    Device-related Serious Adverse Events (SAEs) within 30 days

    Measured: 30 Days

  8. Safety Endpoint: Symptomatic Recurrence of Pulmonary Embolism

    Symptomatic recurrence of Pulmonary Embolism (PE) within 30 days

    Measured: 30 Days

  9. Efficacy Endpoint: Modified Miller Index Score

    Change in modified Miller Index Score (MMIS) between baseline and 48 hours post-procedure as assessed by CTA

    Measured: 48 Hours

  10. Efficacy Endpoint: Change in Mean Pulmonary Artery Pressure

    Change in mean pulmonary artery pressure measured invasively in the central pulmonary arteries before vs. after the endovascular procedure [measured in mmHg]

    Measured: Procedure

  11. Efficacy Endpoint: Procedural Change in Cardiac Index

    Procedural change in cardiac index [measured in L/min/m^2]

    Measured: Procedure

  12. Efficacy Endpoint: Length of ICU Stay, Associated with Index Procedure

    Length of stay in the ICU associated with the index procedure [measured in days]

    Measured: 30 Days

  13. Efficacy Endpoint: Length of Total Hospital Stay

    Length of total hospital stay [measured in days]

    Measured: 30 Days

  14. Efficacy Endpoint: Post-Index Procedure Hospital Length of Stay

    Post-index-procedure hospital length of stay [measured in days]

    Measured: 30 Days

  15. Efficacy Endpoint: Procedural Reduction in Pulmonary Artery Mean Pressure

    Procedural reduction in pulmonary artery mean pressure [measured in mmHg]

    Measured: Procedure

  16. Efficacy Endpoint: Procedural Reduction in Pulmonary Artery Systolic Pressure

    Procedural reduction in pulmonary artery systolic pressure [measured in mmHg]

    Measured: Procedure

  17. Efficacy Endpoint: Reduction in Total Pulmonary Vascular Resistance

    Procedural reduction in total pulmonary vascular resistance [measured in mmHg ⋅ min/L]

    Measured: Procedure

  18. Efficacy Endpoint: Change from Baseline in Dyspnea Severity by mMRC Score

    Change from baseline in Dyspnea severity by mMRC score at the 48-hour visit

    Measured: 48 Hours

  19. Efficacy Endpoint: Change from Baseline in Dyspnea Severity by mMRC Score

    Change from baseline in Dyspnea severity by mMRC score [Time Frame: at the 30 days visit]

    Measured: 30 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2026
  2. Study start21 Aug 2026 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07685522
Sponsor's protocol ID
26-VIC-0001
Status last verified
Jul 2026
First submitted
18 Jun 2026
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mechanical Thrombectomy in people with Pulmonary Embolism Acute, run by Vicora, Inc. at 2 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shawn M Patterson (7164323545, spatterson@egrethealthcareventure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Endpoint: Major Adverse Events (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07685522.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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