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Vacuum device shows promise for clot removal in 500-Patient study

NCT ID NCT06446024

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the INDIGO Aspiration System, a device that uses a vacuum to remove blood clots from arteries and veins. It included 500 patients in Japan with acute limb ischemia, mesenteric artery occlusion, or severe deep vein thrombosis. The goal was to confirm the device's safety and effectiveness in real-world use.

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 uses vacuum to remove blood clots from blood vessels)
What this could lead to
If successful, this could confirm that the INDIGO system is a safe and effective tool for quickly removing dangerous blood clots, potentially reducing the need for more invasive surgery.
What could go wrong
This is a post-market study, meaning the device is already approved. However, results may not apply to all patients, and risks like bleeding or clot re-formation remain.

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

500 people

The number who actually took part.

Started

Dec 2023

Finished

Jul 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.

Who is studied

The INDIGO System is intended for use in patients with acute lower limb artery occlusion, acute superior mesenteric artery occlusion, or severe acute deep vein thrombosis who require immediate treatment and for whom it is difficult to perform surgical thrombectomy or who are expected to have no effective therapeutic effect.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: Patients who meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis. Exclusion Criteria: Patients who do not meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.

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Conditions

The condition(s) this trial relates to.

arterial occlusion limb ischemia mesenteric vascular occlusion

As listed by the trial registrant

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

Acute DVT of lower extremity Acute limb ischemia Arterial occlusion mesenteric artery superior

Contacts and locations

Locations

  • Nara City Hospital

    Nara, 630-8305, Japan

More trials for these conditions

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