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New device aims to save legs from clot emergencies

NCT ID NCT06747117

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Updated 3 times

Summary

This study is testing a device called the Indigo Aspiration System to remove blood clots from leg arteries in people with acute limb ischemia, a condition where a clot suddenly blocks blood flow. About 300 participants will undergo a procedure where the device sucks out the clot. The main goal is to see if the device can save the limb and restore blood flow safely.

What this could mean

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

Active substance
Indigo Aspiration System (device for mechanical clot removal)
What this could lead to
If successful, this could provide a safe and effective way to quickly restore blood flow in leg arteries, potentially saving limbs from amputation.
What could go wrong
This is an early-stage study (no phase specified) with 300 participants, so results may not apply to all patients. Risks include bleeding, vessel damage, or the device failing to remove the clot.

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 300 people

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

Started

May 2025

Expected to finish

Jan 2029

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 that present with LE ALI who are eligible for mechanical thrombectomy using the Indigo Aspiration System

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: * Age ≥18 years * Patients with a confirmed diagnosis of lower limb arterial occlusion located in the common iliac or below, with a minimum of 2 cm of proximal patency in the common iliac * Acute occlusion with symptom duration of 14 days or less at presentation * ALI Rutherford Category I, IIa or IIb * First-line treatment with the Indigo Aspiration System using Computer Assisted Vacuum Thrombectomy (CAVT) aspiration tubing * Informed consent is obtained from either patient or legally authorized representative (LAR) per Institutional Review Board/Ethics Committee requirements * Previously enrolled patients presenting with a new acute occlusion in the contralateral limb meeting all eligibility criteria may be re-enrolled if the new acute occlusion is greater than 30 days from the initial index procedure Exclusion Criteria: * Life expectancy \<1 year * Target vessel size \<2 mm * Target thrombus is in the aorta or isolated profunda artery * Prior major amputation (proximal to the tarsometatarsal joint) in the target limb * Prior minor amputation in the target limb within the past 6 months that is not completely healed or cannot bear weight * LE ALI secondary to dissection, vasculitis, or target vessel trauma, including iatrogenic etiology from treatment of a proximal location in the target limb, and non-thrombotic material such as tumor fragments, fat emboli, septic emboli, and foreign bodies * Target thrombus in a vein bypass graft, previously revised bypass grafts, bypass grafts placed \< 3 months prior to index ALI symptom onset, or bypass grafts with a distal anastomosis below the popliteal artery * Treatment of the index event with thrombolytics or any other endovascular or open surgical method prior to enrollment * Pregnancy * Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated * Other medical, behavioral, 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 * 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

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome limb ischemia

As listed by the trial registrant

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

Le ali Lower extremity acute limb ischemia

How to take part

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

  1. The places running it

    44 sites in 7 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

  • ASST Degli Spedali Civili di Brescia

    RECRUITING

    Brescia, 25123, Italy

  • Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

    RECRUITING

    Miami, Florida, 33176, United States

  • Baylor Scott & White The Heart Hospital - Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • Baylor St. Luke's Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Christiana Care Health Services, Inc.

    RECRUITING

    Newark, Delaware, 19713, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Community Hospital

    RECRUITING

    Munster, Indiana, 46321, United States

  • Community Memorial Hospital

    RECRUITING

    Ventura, California, 93003, United States

  • Dartmouth Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03766, United States

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Flinders Medical Centre

    RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • HonorHealth Scottsdale Osborn Medical Center

    RECRUITING

    Scottsdale, Arizona, 85251, United States

  • Indiana University Health Methodist Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Institut Jantung Negara Sdn Bhd

    RECRUITING

    Kuala Lumpur, Malaysia

  • Jackson-Madison County General Hospital

    RECRUITING

    Jackson, Tennessee, 38301, United States

  • Klinikum Stuttgart - Katharinenhospital

    RECRUITING

    Stuttgart, 70174, Germany

  • Lausanne University Hospital

    RECRUITING

    Lausanne, 1005, Switzerland

  • Lexington Medical Center

    RECRUITING

    West Columbia, South Carolina, 29169, United States

  • Manatee Memorial Hospital

    RECRUITING

    Bradenton, Florida, 34208, United States

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • NC Heart and Vascular Research, LLC

    RECRUITING

    Raleigh, North Carolina, 27607, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • OSF Saint Francis Medical Center

    WITHDRAWN

    Peoria, Illinois, 61637, United States

  • Ospedale Policlinico San Martino, Genova

    RECRUITING

    Genoa, Italy

  • Prisma Health Greenville Memorial Hospital

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Radiology and Imaging Specialists

    RECRUITING

    Lakeland, Florida, 33805, United States

  • Royal North Shore Hospital

    RECRUITING

    Sydney, NSW 2065, Australia

  • Saint Louis University Hospital

    RECRUITING

    St Louis, Missouri, 63104, United States

  • Sanger Heart & Vascular Institute

    RECRUITING

    Concord, North Carolina, 28204, United States

  • Sharp Memorial Hospital

    RECRUITING

    San Diego, California, 92123, United States

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

  • The Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • TriHealth Good Samaritan Hospital

    RECRUITING

    Cincinnati, Ohio, 45220, United States

  • UFMG Hospital Risoleta Tolentino Neves

    RECRUITING

    Belo Horizonte, 31744-012, Brazil

  • UMass Memorial Medical Center

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • UNC Medical Center Hospital

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Florida Shands Hospital

    RECRUITING

    Gainesville, Florida, 32608, United States

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Universitätsklinik Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Universitätsklinikum Köln

    RECRUITING

    Cologne, Germany

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • William P. Clements Jr. University Hospital

    RECRUITING

    Dallas, Texas, 75235, United States

  • Yale New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06520, United States

More trials for these conditions

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