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New device may improve treatment for dangerous lung clots

NCT ID NCT05684796

Disease control Sponsor: Penumbra Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This study tested whether adding a mechanical clot-removal device (Indigo Aspiration System) to standard blood thinners is safer and more effective than blood thinners alone for people with intermediate-high risk pulmonary embolism (a serious blood clot in the lung). About 100 adults aged 18-80 with confirmed clots in major lung arteries participated. The main goal was to see if the combination treatment improved heart strain and reduced complications within 48 hours.

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

100 people

The number who actually took part.

Started

Nov 2023

Finished

Sep 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. Age 18-80 years old 2. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less 3. Objectively confirmed acute PE, based on computed tomographic pulmonary angiography (CTPA) imaging showing a filling defect in at least one main or proximal lobar pulmonary artery 4. Classification of intermediate high-risk PE as demonstrated by right ventricular dysfunction with RV/LV ratio ≥1.0 on CTPA and elevated cardiac biomarkers, including cardiac troponin, BNP, and/or NT-pro BNP above the upper limit of normal 5. Jugular or femoral access deemed suitable to accommodate pulmonary artery intervention with the Indigo Aspiration System 6. Informed consent is obtained from either the patient or legally authorized representative (LAR) Exclusion Criteria: 1. Administration of thrombolytic agents or glycoprotein IIb/IIIa receptor antagonist within 30 days prior to baseline imaging 2. Hemodynamic instability with any of the following present: 1. Cardiac arrest 2. Obstructive shock or persistent hypotension defined as systolic blood pressure (BP) \<90 mmHg or an acute drop in systolic BP ≥40 mmHg for \>15 min, or requiring vasopressor or inotropic support to achieve a systolic BP ≥90 mmHg 3. Patients on ECMO 4. National Early Warning Score (NEWS) 2 ≥9 5. History, imaging or hemodynamic findings consistent with chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis 6. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, that catheter-based intervention is not appropriate for the patient 7. Allergy, hypersensitivity, or heparin induced thrombocytopenia (HIT) 8. Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated 9. \<45 mL/min creatinine clearance 10. Severe active infection (e.g. sepsis) requiring treatment at time of enrollment 11. Active bleeding or disorders contraindicating anticoagulant therapy 12. Hemoglobin \<10 g/dL 13. Platelets \<100,000/μL 14. INR \>3 15. Cardiovascular or pulmonary surgery within last 7 days 16. Primary brain or metastatic brain cancer 17. Life expectancy \<90 days 18. Pregnancy 19. Intracardiac thrombus (right atrium, right ventricle clot in transit) or thrombus in the inferior vena cava identified on baseline imaging 20. Current participation in another investigational drug or device trial that may confound the results of this trial. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies. 21. Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the trial, including compliance with follow-up requirements, or that could impact the scientific integrity of the trial

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Conditions

The condition(s) this trial relates to.

pulmonary embolism

As listed by the trial registrant

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

Pulmonary embolism acute

Contacts and locations

Locations

  • Ascension Seton Medical Center Austin

    Austin, Texas, 78705, United States

  • Auckland City Hospital

    Auckland, New Zealand

  • Baylor University Medical Center

    Dallas, Texas, 75226, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cooper Health System

    Camden, New Jersey, 08103, United States

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073, United States

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9, Canada

  • Joseph Maxwell Cleland Atlanta VA Medical Center

    Decatur, Georgia, 30033, United States

  • Kingwood Medical Center

    Kingwood, Texas, 77339, United States

  • Krakowski Szpital Specjalistyczny św. Jana Pawła II

    Krakow, Poland

  • McLaren Bay Heart & Vascular

    Bay City, Michigan, 48708, United States

  • Metropolitan Methodist Hospital

    San Antonio, Texas, 78212, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • Northwestern Memorial

    Chicago, Illinois, 60611, United States

  • Radiology and Imaging Specialists/Lakeland Regional

    Lakeland, Florida, 33801, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • St. Elizabeth Edgewood Hospital

    Edgewood, Kentucky, 41017, United States

  • The University of Arizona - Banner

    Tucson, Arizona, 85719, United States

  • UCLA Medical Center

    Los Angeles, California, 90024, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • Wellstar Kennestone

    Marietta, Georgia, 30060, United States

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