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New Clot-Busting device could save lives in pulmonary embolism

NCT ID NCT05907564

Disease control Sponsor: Inquis Medical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial is testing a device called the Aventus Thrombectomy System, which suctions out blood clots from the lungs in people with acute pulmonary embolism. The study involves 130 participants aged 18 to 80. The goal is to see if the device is safe and effective at improving blood flow and reducing major complications like death or bleeding.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aventus Thrombectomy System (a device that suctions out blood clots from the lungs)
What this could lead to
If it works, this could offer a safer, faster way to remove dangerous blood clots from the lungs, potentially reducing death and serious complications.
What could go wrong
This is an early-stage study with only 130 participants, so results may not apply to everyone. Risks include bleeding, vessel injury, or the device not working as expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

120 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 and ≤ 80 years 2. Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures 3. Subject is willing and able to comply with all protocol required follow-up visits 4. PE (pulmonary embolism) symptom(s) duration ≤ 14 days from index procedure 5. PE diagnosis ≤ 48 hours prior to index procedure 6. CTA (computed tomography angiography) evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery based on Investigator determination) 7. CTA evidence of dilated RV (right ventricle) with an RV/LV (left ventricle) ratio of ≥ 0.9 at baseline based on Investigator determination 8. Systolic blood pressure (SBP) ≥ 90 mmHg without need for vasopressors (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with intravenous fluids prior to index procedure) 9. Stable heart rate \< 130 BPM prior to index procedure 10. Subject is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment Exclusion Criteria: 1. Prior PE ≤ 180 days from index procedure 2. Current hospitalization for other condition(s) 3. Thrombolytic use ≤ 14 days of baseline CTA 4. Pulmonary hypertension with peak pulmonary artery systolic pressure \> 70 mmHg by right heart catheterization 5. FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90% 6. Hematocrit \< 28% within 6 hours of index procedure 7. Platelets \< 100,000/μL 8. Serum creatinine \> 1.8 mg/dL 9. International normalized ratio (INR) \> 3 10. Presence of intracardiac lead in the right ventricle or right atrium placed \< 180 days prior to index procedure 11. Cardiovascular or pulmonary surgery ≤ 7 days prior to index procedure 12. Actively progressing cancer treated by chemotherapeutics 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. Any contraindication to systemic or therapeutic doses of heparin or anticoagulants 22. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated 23. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for aspiration thrombectomy intervention such as the inability to navigate to target location, predominantly chronic clot or non-clot embolus 24. Life expectancy of \< 90 days, as determined by Investigator 25. Female who is pregnant or nursing 26. Current participation in another investigational drug or device treatment study that has not reached the primary endpoint or the Investigator feels would impact their ability to participate in this clinical trial 27. Subject has known residual Iliac Deep Vein Thrombosis (DVT), Inferior Vena Cava (IVC) clot or clot in transit (right atrium and/or right ventricular) 28. Subject on extracorporeal membrane oxygenation (ECMO)

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Embolism Embolism and Thrombosis lung disorder pulmonary embolism respiratory system disorder Thromboembolism vascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Embolism Embolism and thrombosis Lung diseases Pulmonary embolism Respiratory tract diseases Vascular diseases

Contacts and locations

Locations

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007, United States

  • Ascension Providence

    Southfield, Michigan, 48075, United States

  • Ascension Seton

    Austin, Texas, 78705, United States

  • Ascension St. John

    Tulsa, Oklahoma, 74006, United States

  • Ascension St. Vincent

    Indianapolis, Indiana, 46260, United States

  • Centennial Medical Center (HCA)

    Nashville, Tennessee, 37203, United States

  • CentraCare Heart and Vascular

    Saint Cloud, Minnesota, 56303, United States

  • El Camino Health

    Mountain View, California, 94040, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666, United States

  • Honor Health

    Scottsdale, Arizona, 85258, United States

  • Ichan School of Medicine at Mount Sinai

    New York, New York, 10019, United States

  • McLaren Health Care

    Bay City, Michigan, 48708, United States

  • Medstar

    Washington D.C., District of Columbia, 20010, United States

  • MemorialCare

    Long Beach, California, 90806, United States

  • NorthBay Medical Center

    Fairfield, California, 94533, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ochsner Health

    New Orleans, Louisiana, 70121, United States

  • OhioHealth Research Institute

    Columbus, Ohio, 43214, United States

  • ProMedica - Jobst Vascular

    Toledo, Ohio, 43606, United States

  • Sutter Health

    Sacramento, California, 95816, United States

  • The Miriam Hospital

    Providence, Rhode Island, 02906, United States

  • University Hospitals

    Cleveland, Ohio, 44106, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.