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New Clot-Busting device shows promise for lung blockages

NCT ID NCT05560763

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a device called the FlowTriever2 Catheter in 50 people with acute pulmonary embolism (blood clots in the lungs). The device was used to mechanically remove clots from the lung arteries. Researchers measured safety by tracking serious side effects and effectiveness by checking changes in lung artery pressure. The goal was to see if this approach could quickly improve blood flow and reduce harm from the clots.

What this could mean

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

Active substance
FlowTriever2 Catheter (a device inserted into blood vessels to mechanically remove clots from the lung arteries)
What this could lead to
If successful, this device could offer a way to quickly reduce dangerous blood clots in the lungs, potentially improving blood flow and reducing complications.
What could go wrong
This was a small, single-arm study with only 50 participants, so results may not apply to everyone. There are risks of bleeding, vessel injury, or worsening symptoms during the procedure.

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

50 people

The number who actually took part.

Started

Feb 2023

Finished

Sep 2024

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 to 75 years

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: * Clinical signs and symptoms consistent with acute PE * PE symptom duration ≤ 14 days * CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery) * RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment based on Investigator's interpretation of RV/LV ratio) * Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids) * Stable heart rate \< 130 BPM prior to procedure * Patient is deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment. * FlowTriever2 Catheter enters the vasculature Exclusion Criteria: * Thrombolytic use within 30 days of baseline CTA * Pulmonary hypertension with peak pulmonary artery pressure \> 70 mmHg by right heart catheterization * Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg * FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90% * Hematocrit \< 28% (NOTE: hematocrit required within 6 hours of index procedure) * Platelets \< 100,000/μL * Serum creatinine \> 1.8 mg/dL * INR \> 3 * Major trauma Injury Severity Score (ISS) \> 15 * Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months * Cardiovascular or pulmonary surgery within last 7 days * Actively progressing cancer * Known bleeding diathesis or coagulation disorder * Left bundle branch block * History of severe or chronic pulmonary arterial hypertension * History of chronic left heart disease with left ventricular ejection fraction ≤ 30% * History of uncompensated heart failure * History of underlying lung disease that is oxygen dependent * History of chest irradiation * History of heparin-induced thrombocytopenia (HIT) Any contraindication to systemic or therapeutic doses heparin or anticoagulants * Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated * Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location, predominately chronic clot, or non-clot embolus) * Life expectancy of \< 90 days, as determined by Investigator * Female who is pregnant or nursing * Current participation in another investigational drug or device treatment study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Baptist Health

    Louisville, Kentucky, 40207, United States

  • Carondelet St. Joseph's Hospital

    Tucson, Arizona, 85711, United States

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404, United States

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104, United States

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • Virtua Health

    Camden, New Jersey, 08103, United States

  • Yale University

    New Haven, Connecticut, 06511, United States

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