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Can a new device suck out deadly lung clots?

NCT ID NCT06062329

Disease control Sponsor: Imperative Care, 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests a device called the Symphony Thrombectomy System in people with acute pulmonary embolism, a condition where blood clots block arteries in the lungs. The device is designed to restore blood flow by suctioning out or breaking up the clots. The study will check how safe the device is and whether it reduces strain on the heart, as seen on CT scans, within 48 hours of the procedure.

What this could mean

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

Active substance
Symphony Thrombectomy System, a device that removes blood clots from the lungs using aspiration and mechanical clot engagement
What this could lead to
If successful, this device could offer a new way to quickly clear life-threatening blood clots in the lungs, potentially reducing complications and improving recovery for people with acute pulmonary embolism.
What could go wrong
This is an early-stage trial with a moderate number of participants, so the device may not prove safer or more effective than existing treatments. There are risks of bleeding, device-related injury, or other serious adverse events.

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

110 people

The number who actually took part.

Started

Dec 2023

Finished

May 2025

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. CTA evidence of acute PE within ≤14 days 2. Clinical signs and symptoms consistent with acute PE. 3. Systolic BP ≥90 mmHg with evidence of dilated RV with an RV/LV ratio \>0.9 (based on Investigator's assessment of RV/LV ratio) 4. Stable heart rate \<130 BPM prior to procedure 5. Subject is between 18 and 80 years of age 6. Subject is willing to sign an IRB-approved informed consent form 7. Subject is willing and able to comply with protocol follow-up Exclusion Criteria: 1. Thrombolytic use within 14 days of baseline CTA 2. International Normalized Ratio (INR) \>3 3. Platelets \<100,000/µL 4. Kidney dysfunction as confirmed by serum creatinine \>1.8 mg/dL or GFR \<45 mL/min 5. Hematocrit \<28% or hemoglobin \<9 g/dL 6. Systolic BP \<90 mmHg for 15 min or requirement of inotropic support to maintain systolic BP ≥90 mmHg any time after admission 7. Experienced cardiac arrest 8. Has left bundle branch block 9. Known bleeding diathesis or coagulation disorder 10. Presence of intracardiac lead in the right ventricle or right atrium 11. Presence of intracardiac thrombus 12. Major trauma within the past 14 days 13. Cardiovascular or pulmonary surgery within last 7 days 14. Known serious, uncontrolled sensitivity to radiographic agents 15. Contraindication to anticoagulants, i.e., heparin or alternative 16. Patient on extracorporeal membrane oxygenation (ECMO) 17. Cancer requiring active chemotherapy 18. Heparin-induced thrombocytopenia (HIT) 19. Pulmonary hypertension with peak pulmonary artery pressure \>70 mmHg by right heart catheterization. 20. History of chronic severe pulmonary hypertension, and/or chronic left heart disease with left ventricular ejection fraction ≤30% 21. Life expectancy \<90 days as determined by investigator 22. Pregnant or nursing 23. COVID-19 positive at hospital admission 24. Current participation in another investigational study 25. Evidence such as imaging or other that suggests the subject is not appropriate for this procedure (e.g., target vessel size is too small to accommodate 16F or 24F catheters).

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Embolism pulmonary embolism Thromboembolism thrombotic disease vascular disorder venous thromboembolism

As listed by the trial registrant

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

Acute pulmonary embolism Cardiovascular diseases Emboli, pulmonary Embolism Thromboembolism Thrombosis Thrombus; embolism Vascular diseases

Contacts and locations

Locations

  • Ascension St John Hospital

    Detroit, Michigan, 48236, United States

  • Bon Secours Mercy Health, Inc

    Cincinnati, Ohio, 45237, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Corewell Health

    Grand Rapids, Michigan, 49503, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Endeavor Health

    Glenview, Illinois, 60026, United States

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32256, United States

  • Huntsville Hospital

    Huntsville, Alabama, 35801, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Medical City Dallas Hospital

    Dallas, Texas, 75230, United States

  • Medical City Fort Worth Hospital

    Fort Worth, Texas, 76104, United States

  • NYU Grossman School of Medicine

    New York, New York, 10016, United States

  • Northwell Health

    Mount Kisco, New York, 10549, United States

  • Prisma Health

    Greenville, South Carolina, 29605, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308, United States

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093, United States

  • William Beaumont Hospital - Royal Oak

    Royal Oak, Michigan, 48073, United States

More trials for these conditions

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