Can a Clot-Removing device ease acute pulmonary embolism?
NCT ID NCT06152341
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This trial tests a device called the ATC System in people with acute pulmonary embolism, a condition where blood clots block arteries in the lungs. The device aims to mechanically remove the clots and restore blood flow. Researchers will measure how well it reduces heart strain and check for safety issues like bleeding or vessel damage. The study enrolls about 30 adults with recent symptoms and evidence of clots in the main lung arteries.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ATC System, a device designed to mechanically remove blood clots from the pulmonary arteries
- What this could lead to
- If it works, this device could offer a new way to quickly clear life-threatening blood clots in the lungs, potentially reducing heart strain and improving survival.
- What could go wrong
- This is an early, small study with only 30 participants, so results may not apply broadly. The procedure carries risks like bleeding, vessel injury, or worsening of the condition.
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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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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May 2027
An estimate. End dates often move.
- 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 90 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: 1. Patient is ≥ 18 and ≤ 90 years old 2. Clinical signs and symptoms consistent with acute PE for \< 14 days 3. CTA evidence of proximal PE 4. RV/LV ratio \> 0.9 5. Systolic BP ≥90 mmHg without the need for vasopressors 6. Stable heart rate (HR) \< 130 BPM prior to procedure 7. Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment 8. Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures Exclusion Criteria: 1. Prior PE \< 180 days from index procedure 2. Thrombolytic use \< 30 days prior to baseline CTA 3. Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) \>70 mmHg by right heart catheterization 4. FiO2 requirement \>40% or \>6 LPM to keep oxygen saturation \>90% 5. Hematocrit \<28% 6. Platelets count \<100,000/µL 7. Serum creatinine \>1.8 mg/dL 8. International normalized ratio (INR) \>3 9. Major trauma injury severity score (ISS) \>15 prior to screening assessment 10. Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment 11. Cardiovascular or pulmonary surgery within 7 days of index procedure 12. Actively progressing cancer treated by chemotherapeutics 13. Known bleeding diathesis or coagulation disorder 14. Left bundle branch block 15. History of severe or chronic pulmonary arterial hypertension 16. History of chronic left heart disease with left ventricular ejection fraction ≤ 30% 17. History of decompensated heart failure 18. History of underlying lung disease that is oxygen dependent 19. History of chest irradiation 20. History of heparin-induced thrombocytopenia (HIT) 21. Contraindication to systemic or therapeutic doses of anticoagulants 22. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated 23. Imaging evidence or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention 24. Life expectancy \<90 days, as determined by investigator such as stage 4 cancer, frailty or severe COVID infections 25. Female who is pregnant or nursing 26. 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites in 2 countries. The list below names each one and where it is.
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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.
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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
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Centro de Intervenciones Cardiovasculares
Santiago de los Caballeros, Santiago Province, Dominican Republic
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Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012-000, Brazil
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Instituto do Coracao
São Paulo, São Paulo, 05403-000, Brazil
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Other studies related to the condition(s) this trial covers.
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- Can a simple electrical scan spot dangerous lung clots without radiation?
- New suction device aims to quickly clear lung clots in emergency setting
- Blood test may spot hidden heart danger in lung clots
- Heart patients get flu shot at discharge to prevent future attacks