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Study of the Indigo Aspiration System for Pulmonary Embolism

This study is looking at the long-term safety and results of using the Indigo Aspiration System to treat pulmonary embolism (PE), a condition where a blood clot blocks an artery in the lungs. Researchers want to understand how well this system works and if it's safe in a real-world setting. You might be able to join if you are at least 18 years old, have symptoms of acute PE for 14 days or less, and have a specific measurement (RV/LV ratio) of 0.9 or higher, as seen on a CT scan or echocardiogram. The study will measure safety by looking at major problems within 48 hours and performance by checking changes in your RV/LV ratio after the procedure. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will watch what happens to patients who are treated with the Indigo Aspiration System. The study plans to include about 1500 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and performance will be measured at 48 hours after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04798261

Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System

Recruiting
Not specifiedAges 18+Observational
Penumbra Inc.
~1,500 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Indigo Aspiration System

At a glance

Recruiting sites
75 of 79 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety: Composite of major adverse events
Measured over 48 hours
+1 more outcome measured

Conditions

Pulmonary Embolism

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Pulmonary Embolism

NCT04798261

Where you'd take part

This study runs at 79 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AdventHealth Orlando

    Orlando, Floridano site contact published

    Recruiting

  • Ascension St. John Hospital

    Detroit, Michiganno site contact published

    Recruiting

  • Baptist Health Miami Cardiac and Vascular Institute

    Miami, Floridano site contact published

    Recruiting

  • Bellevue Hospital Center

    New York, New Yorkno site contact published

    Recruiting

  • Blake Medical Center/Nova Clinical Research

    Brandenton, Floridano site contact published

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, Californiano site contact published

    Recruiting

  • Charlton Memorial Hospital

    Fall River, Massachusettsno site contact published

    Recruiting

  • Christiana Care Hospital

    Newark, Delawareno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • John Moriarty, MD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles
  • Aleksander Araszkiewicz, MD, PhD · PRINCIPAL_INVESTIGATOR · Uniwersytecki Szpital Kliniczny w Poznaniu

Who to contact

Joanne Krasnoff
[email protected]
650-455-4462
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Safety: Composite of major adverse events48 hours

    A composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury

  • Performance: Change in RV/LV Ratio48 hours post-procedure

    Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available)