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New device sucks out dangerous blood clots in leg veins

NCT ID NCT05003843

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This study is testing a device called the Indigo Aspiration System that suctions out blood clots in people with deep vein thrombosis (DVT) in the leg. The goal is to see if it safely and effectively removes the clot and restores blood flow. About 229 participants with recent DVT symptoms are being treated with this device and followed for complications.

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 (a device that suctions out blood clots)
What this could lead to
If successful, this could provide a safer, more effective way to quickly remove large blood clots in the leg veins, potentially reducing long-term damage and complications.
What could go wrong
This is a single-arm study without a comparison group, so benefits may be overstated. Risks include bleeding, device-related injury, or the clot returning.

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

229 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Jan 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.

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: * Unilateral lower extremity DVT occlusion involving iliac and/or common femoral veins with up to 2 cm extension in the inferior vena cava (IVC) or femoral in combination with iliac veins, including patients with extension of clot into the contralateral common iliac vein Note: Patients with non-iliofemoral DVT in the contralateral limb, who do not require endovascular treatment, may be enrolled * Acute thrombotic or thromboembolic occlusion with symptom duration of 14 days or less at presentation * Frontline treatment with Indigo Aspiration System in the target venous segment per Investigator decision * Patient is ≥18 years of age * Informed consent is obtained per Institutional Review Board requirements Exclusion Criteria: * Contraindication to systemic or therapeutic doses of anticoagulants * Contraindication to iodinated contrast venography that cannot be adequately premedicated * Complete infrarenal IVC occlusion * In the index leg: prior DVT * Prior stent in target venous segment * Treatment of index DVT with thrombolytics within 14 days prior to index procedure * Pulmonary embolism (PE) defined as either high (systolic blood pressure \< 90 mmHg and/or patient on IV vasoactive medication to support blood pressure), or intermediate high-risk PE, as defined by the European Society Guideline on management of PE. Low risk PE and/or intermediate low risk PE can be enrolled. * Known coagulation disorders both acquired (e.g., Heparin Induced Thrombocytopenia, etc.) or genetic (e.g., Factor V Leiden, etc.), thrombophilia, or hypercoagulable state * Pregnant patients * Life expectancy \<1 year due to comorbidities * Primary brain, metastatic cancer or marrow malignancies * 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. * 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 * Pre-existing malpositioned stent(s) that obstructs the ostium of the index iliac vein and contacts the vena cava wall as demonstrated by venography prior to the index procedure * Congenital anatomic anomalies of the IVC or iliac veins

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Conditions

The condition(s) this trial relates to.

venous thromboembolism Venous Thrombosis

As listed by the trial registrant

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

Deep vein thrombosis DVT

Contacts and locations

Locations

  • BUMC - Dallas (Scott & White)

    Dallas, Texas, 75246, United States

  • Baptist of Miami

    Miami, Florida, 33176, United States

  • Christ Cincinnati

    Cincinnati, Ohio, 45219, United States

  • Christiana Care

    Newark, Delaware, 19713, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Hackensack Medical Center

    Hackensack, New Jersey, 07601, United States

  • Holston Valley Medical

    Kingsport, Tennessee, 37660, United States

  • Indiana University Health

    Indianapolis, Indiana, 46290, United States

  • Jewish Barnes Hospital

    St Louis, Missouri, 63110, United States

  • Kaleida University at Buffalo

    Buffalo, New York, 14203, United States

  • LSU Hospital Shreveport

    Shreveport, Louisiana, 71103, United States

  • Lafayette General/Cardiovascular Institute of the South

    Lafayette, Louisiana, 70503, United States

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602, United States

  • Lenox Hill Hospital

    New York, New York, 10075, United States

  • Long Beach Medical Center

    Long Beach, California, 90806, United States

  • Lovelace Heart

    Albuquerque, New Mexico, 87102, United States

  • MUSC

    Charleston, South Carolina, 29425, United States

  • McLaren Greater Lansing

    East Lansing, Michigan, 48910, United States

  • MedStar Washington

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

  • Memorial Jacksonville

    Jacksonville, Florida, 32216, United States

  • Mount Sinai Miami

    Miami Beach, Florida, 33140, United States

  • Mount Sinai NY

    New York, New York, 10029, United States

  • NC Heart and Vascular Research

    Raleigh, North Carolina, 27607, United States

  • NYU

    New York, New York, 11220, United States

  • Nebraska Methodist

    Omaha, Nebraska, 68118, United States

  • Northwestern Memorial

    Chicago, Illinois, 60611, United States

  • Protestant Memorial Medical Center, Inc

    Belleville, Illinois, 62226, United States

  • Radiology and Imaging Specialists

    Lakeland, Florida, 33805, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Sarasota Memorial

    Sarasota, Florida, 34239, United States

  • Sentara

    Norfolk, Virginia, 23507, United States

  • Sharp Grossmont

    La Mesa, California, 91942, United States

  • St. Joseph Mercy Ann Arbor Hospital

    Ann Arbor, Michigan, 48197, United States

  • St. Vincent

    Indianapolis, Indiana, 46260, United States

  • Stony Brook University

    Stony Brook, New York, 11794, United States

  • TriHealth

    Cincinnati, Ohio, 45242, United States

  • UCLA

    Los Angeles, California, 90095, United States

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655, United States

  • UPenn

    Philadelphia, Pennsylvania, 19104, United States

  • University of Kentucky

    Lexington, Kentucky, 40506, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Weill Cornell Medicine

    New York, New York, 10021, United States

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