Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New device aims to suck out deadly lung clots in major trial

NCT ID NCT04798261

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Updated 2 times

Summary

This study is testing a device called the Indigo Aspiration System to remove blood clots from the lungs in people with a pulmonary embolism. The goal is to see if it is safe and helps patients recover better in the long run. About 1500 adults with recent clots will take part.

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.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Feb 2028

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.

Who is studied

Patients with acute pulmonary embolism

Ages

18 years and older

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. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less 2. RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram 3. Frontline endovascular treatment with the Indigo Aspiration System per IFU 4. Patient is ≥ 18 years of age 5. Informed consent obtained per Institutional Review Board/Ethics Committee requirements Exclusion Criteria: 1. Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin) 2. Stage IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation 3. Known serious, uncontrolled sensitivity to radiographic agents 4. Life expectancy \< 180 days 5. Patients on ECMO 6. Pregnant patients 7. Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies 8. 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 study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Pulmonary embolism are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    75 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Ascension St. John Hospital

    RECRUITING

    Detroit, Michigan, 48236, United States

  • Baptist Health Miami Cardiac and Vascular Institute

    RECRUITING

    Miami, Florida, 33176, United States

  • Bellevue Hospital Center

    RECRUITING

    New York, New York, 10016, United States

  • Blake Medical Center/Nova Clinical Research

    RECRUITING

    Brandenton, Florida, 34209, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Charlton Memorial Hospital

    RECRUITING

    Fall River, Massachusetts, 02720, United States

  • Christ Hospital

    COMPLETED

    Cincinnati, Ohio, 45219, United States

  • Christiana Care Hospital

    RECRUITING

    Newark, Delaware, 19718, United States

  • Christus Mother Frances Hospital

    RECRUITING

    Tyler, Texas, 75701, United States

  • Columbia University Medical Center/NYPH

    RECRUITING

    New York, New York, 10032, United States

  • Cooper Health System

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Delray Medical Center, Inc.

    RECRUITING

    Delray Beach, Florida, 33484, United States

  • Europejskie Centrum Zdrowia Otwock

    RECRUITING

    Otwock, 05-400, Poland

  • Flinders Medical Centre

    RECRUITING

    Bedford Park, South Australia, 5043, Australia

  • GRN-Klinik Weinheim

    COMPLETED

    Weinheim, 69469, Germany

  • Glenbrook Hospital

    RECRUITING

    Glenview, Illinois, 60026, United States

  • HCA Florida Northside Hospital

    RECRUITING

    Petersburg, Florida, 33709, United States

  • Hillcrest Medical Center

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • Hospital Clínico Universitario Lozano Blesa

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Santa Lucia Sul

    RECRUITING

    Brasília, 70390-700, Brazil

  • Hospital Universitario Virgen de la Nieves

    RECRUITING

    Granada, 18014, Spain

  • Hospital de Santa Cruz

    RECRUITING

    Carnaxide, 2790-134, Portugal

  • Houston Methodist The Woodlands Hospital

    RECRUITING

    The Woodlands, Texas, 77385, United States

  • INTEGRIS Baptist Medical Center

    RECRUITING

    Oklahoma City, Oklahoma, 73112, United States

  • Inselspital, Universitätsspital Bern

    RECRUITING

    Bern, CH-3010, Switzerland

  • Jackson Memorial Hospital

    RECRUITING

    Miami, Florida, 33136, United States

  • Jackson-Madison County General Hospital

    RECRUITING

    Jackson, Tennessee, 38301, United States

  • KUMC

    COMPLETED

    Kansas City, Kansas, 66160, United States

  • Kettering Medical Center

    RECRUITING

    Kettering, Ohio, 45429, United States

  • Krakowski Szpital Specjalistyczny św. Jana Pawła II

    RECRUITING

    Krakow, 31-202, Poland

  • LSU Health Sciences Center

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Leids Universitair Medisch Centrum

    RECRUITING

    Leiden, 2333 ZA, Netherlands

  • Long Beach Medical Center

    RECRUITING

    Long Beach, California, 90806, United States

  • Lovelace Health System

    RECRUITING

    Albuquerque, New Mexico, 87102, United States

  • Loyola University Medical Center

    RECRUITING

    Maywood, Illinois, 600153, United States

  • Manatee Memorial Hospital

    RECRUITING

    Bradenton, Florida, 34205, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • MedStar Washington Hospital Center

    RECRUITING

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

  • MedUni Graz-Univ.-Klinikum Graz

    RECRUITING

    Graz, 8036, Austria

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Hospital Belleville

    RECRUITING

    Belleville, Illinois, 62226, United States

  • Mercy Hospital South

    RECRUITING

    St Louis, Missouri, 63128, United States

  • Methodist Hospital Metropolitan

    RECRUITING

    San Antonio, Texas, 78112, United States

  • Miriam Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Mount Carmel East

    RECRUITING

    Columbus, Ohio, 43213, United States

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • NC Heart and Vascular Research

    RECRUITING

    Raleigh, North Carolina, 27607, United States

  • Ospedale Misericordia

    RECRUITING

    Grosseto, 58100, Italy

  • Ospedale San Giovanni Bosco

    RECRUITING

    Torino, 10154, Italy

  • Penn State Health Milton S. Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • ProMedica Toledo Hospital

    RECRUITING

    Toledo, Ohio, 43606, United States

  • Radiology and Imaging Specialists

    RECRUITING

    Lakeland, Florida, 33805, United States

  • Royal Free Hospital

    RECRUITING

    London, NW3 2QG, United Kingdom

  • Royal Sussex County Hospital

    RECRUITING

    Brighton, Sussex, BN2 5BE, United Kingdom

  • SUNY Upstate Medical University

    RECRUITING

    Syracuse, New York, 13210, United States

  • Sentara Norfolk General

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Sharp Memorial Hospital

    RECRUITING

    San Diego, California, 92123, United States

  • St. Francis Hospital and Heart Center

    RECRUITING

    Roslyn, New York, 11576, United States

  • St. Joseph Hospital - BayCare

    RECRUITING

    Tampa, Florida, 33614, United States

  • Staten Island University Hospital

    RECRUITING

    Staten Island, New York, 10305, United States

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

  • Temple University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • TriHealth Good Samaritan Hospital

    RECRUITING

    Cincinnati, Ohio, 45220, United States

  • Turkey Creek Medical Center

    RECRUITING

    Knoxville, Tennessee, 37934, United States

  • UC Irvine Medical Center

    RECRUITING

    Orange, California, 92868, United States

  • UCLA Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • UCSD Jacobs

    RECRUITING

    San Diego, California, 92037, United States

  • UPMC Harrisburg

    RECRUITING

    Harrisburg, Pennsylvania, 17101, United States

  • Universitaetsmedizin Mainz

    RECRUITING

    Mainz, 55131, Germany

  • University Hospital Augusta

    RECRUITING

    Augusta, Georgia, 30901, United States

  • University Hospital of Wales

    RECRUITING

    Cardiff, Wales, CF14 4XW, United Kingdom

  • University of Florida Shands Hospital

    RECRUITING

    Gainesville, Florida, 32608, United States

  • University of Minnesota

    COMPLETED

    Minneapolis, Minnesota, 55455, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • Universitätsmedizin Mannheim

    RECRUITING

    Mannheim, Baden-Wurttemberg, 68167, Germany

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    RECRUITING

    Poznan, 61-848, Poland

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

    RECRUITING

    Warsaw, 02-005, Poland

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

More trials for these conditions

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