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New Clot-Busting device shows promise for lung blockages
NCT ID NCT05560763
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
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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
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50 people
The number who actually took part.
- Started
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Feb 2023
- Finished
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Sep 2024
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Baptist Health
Louisville, Kentucky, 40207, United States
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Carondelet St. Joseph's Hospital
Tucson, Arizona, 85711, United States
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Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
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Oklahoma Heart Institute
Tulsa, Oklahoma, 74104, United States
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University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
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Virtua Health
Camden, New Jersey, 08103, United States
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Yale University
New Haven, Connecticut, 06511, United States
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Other studies related to the condition(s) this trial covers.
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