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New Clot-Busting device tested for lung emergency

NCT ID NCT06189313

Disease control Sponsor: Argon Medical Devices 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a device called the Cleaner Pro Thrombectomy System, which is threaded through a blood vessel to suction out clots in the lungs of people with acute pulmonary embolism. The trial aims to see if the device safely reduces heart strain and avoids major complications. It plans to enroll 125 adults with recent clot symptoms and evidence of heart strain.

What this could mean

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

Active substance
Cleaner Pro Thrombectomy System (a catheter-based device to remove blood clots)
What this could lead to
If successful, this device could offer a new way to quickly remove dangerous clots from the lungs, potentially reducing heart strain and improving outcomes for people with acute pulmonary embolism.
What could go wrong
This trial is currently suspended, and it is still early—results may not confirm the device is safe or effective. Risks include bleeding, vessel injury, or other serious complications.

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

About 125 people

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

Started

Jan 2025

Expected to finish

Feb 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.

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: * At least 18 years of age at the time of consent * Clinical signs, symptoms, and presentation consistent with acute PE * Onset of PE symptoms occurred within 14 days of presentation * Filling defect in at least one main or lobar pulmonary artery evidenced by CTA * RV dysfunction on CTA or echocardiography defined as RV/LV ratio \>0.9 Exclusion Criteria: * tPA use within 14 days prior to baseline CTA * Systolic BP \<90 mmHg for 15 min or the requirement of inotropic support to maintain systolic BP ≥90 mmHg * Diagnosis of pulmonary hypertension primary type I or CTEPH; if patient does not have diagnosis of pulmonary hypertension but peak PA \>70 mmHg by right heart catheterization or elevated main pulmonary artery to aorta ratio (MPA:A), up to investigator discretion. * History of severe or chronic pulmonary hypertension * FiO2 requirement \>40% or \>6 LPM to keep oxygen saturations \>90% * Hematocrit \<28% * Platelets \<100,000/µL * Serum creatinine \>1.8 mg/dL * INR \>3 * aPTT (or PTT) \>50 seconds on no anticoagulation * History of heparin-induced thrombocytopenia (HIT) * Recent (within six months) history of stroke, transient ischemic attack (TIA), or intracranial bleeding * Recent (within one month) history of active bleeding from a major organ * Absolute contraindication to anticoagulation * Major trauma such as head trauma, or other active intracranial, or intraspinal disease within 14 days * Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months * Cardiovascular or pulmonary surgery within last 7 days * Cancer which requires active chemotherapy * Known serious, uncontrolled sensitivity to radiographic agents * Life expectancy \<90 days, as determined by investigator * Female who is pregnant * Intracardiac thrombus * Patients who present with cardiac arrest and/or are on extracorporeal membrane oxygenation (ECMO) or ECMO required to perform interventional procedure * Simultaneous participation in another investigational study * Patients with known coagulation disorders such as antiphospholipid, Protein C, and Protein S * Presentation of PE with paradoxical emboli which may be diagnosed by concurrent stroke or concurrent arterialization

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder pulmonary embolism venous thromboembolism

As listed by the trial registrant

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

Acute pulmonary embolism Cardiovascular diseases Pulmonary embolism Venous thromboembolism

How to take part

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

  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Ascension St. John Jane Phillips Medical Center

    Bartlesville, Oklahoma, 74006, United States

  • Ascension St. Vincent Hospital

    Indianapolis, Indiana, 46260, United States

  • BayCare Health System

    Tampa, Florida, 33607, United States

  • Baylor Scott & White The Heart Hospital - Plano

    Plano, Texas, 75093, United States

  • Baylor Scott and White Heart and Vascular Hospital - Dallas

    Dallas, Texas, 75226, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Medstar Health Research Institute

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

  • Promedica Toledo Hospital

    Toledo, Ohio, 43606, United States

  • UMass Chan Medical School

    Worcester, Massachusetts, 01655, United States

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

More trials for these conditions

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