New Clot-Busting device could offer quick relief for lung blood clots
NCT ID NCT05821426
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a new device called the eTrieve PE Kit to remove blood clots from the lungs in people with a moderate-risk pulmonary embolism. About 130 adults will be enrolled to see if the device is safe and effective at improving blood flow and reducing complications. The goal is to offer a faster, less invasive treatment option for this serious condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- eTrieve PE Kit (a device to remove blood clots from the lungs)
- What this could lead to
- If successful, this could provide a new, less invasive way to quickly remove dangerous blood clots from the lungs, potentially reducing complications and hospital stays.
- What could go wrong
- This is an early-stage study with only 130 participants and no comparison group, so results may not apply to everyone. The procedure carries risks like any invasive device, including bleeding or damage to blood vessels.
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 130 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jul 2026
An estimate. Start dates often move.
- Expected to finish
-
Oct 2027
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 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: * Age ≥ 18 years * Clinical signs, symptoms, and presentation consistent with acute pulmonary embolism (PE) * PE symptom duration ≤ 14 days * Filling defect in at least one main or lobar pulmonary artery on CTA * Right ventricle / left ventricle (RV/LV) ratio ≥ 0.9 on CTA (Investigator's reading) * Systolic blood pressure ≥ 90 mmHg * Stable heart rate \< 130 BPM prior to the index procedure * Anatomy that, in the opinion of the interventionalist, allows safe passage of the eTrieve™ catheters * Written informed consent Exclusion Criteria: * Patients with a combined reason for their decompensation (e.g., a patient with both sepsis and PE) * PE within 3 months prior to screening assessment * Thrombolytic use within 30 days prior to baseline CTA * Pulmonary hypertension with peak systolic PAP \> 70 mmHg * Inotrope or vasopressor requirement after fluid administration to keep the systolic blood pressure ≥ 90 mmHg * Fraction of inspired Oxygen (FiO2) requirement \> 40% or supplemental oxygen \> 6 LPM to keep oxygen saturation \> 90% * Any of the following laboratory findings (within 6 hours prior to index procedure): 1. Hematocrit \< 28% 2. Platelets \< 100,000/µL 3. Serum creatinine \> 1.8 mg/dL 4. INR \> 3 * Major trauma Injury Severity Score (ISS) \> 15 within 14 days prior to screening assessment * Intracardiac lead in right ventricle, right atrium or coronary sinus, placed within 6 months prior to screening assessment * Known presence of intracardiac clot * Cardiovascular or pulmonary surgery within last 7 days * Active malignancy and / or on chemotherapy * Known bleeding diathesis or coagulation disorder * Left bundle branch block * History of severe or chronic pulmonary arterial hypertension * History of left ventricular ejection fraction ≤ 30% * History of decompensated heart failure * History of underlying oxygen dependent lung disease * History of chest irradiation * History of Heparin Induced Thrombocytopenia (HIT) * Any contraindication to systemic therapeutic doses of heparin or other anticoagulants * Known anaphylactic reaction to radiographic contrast agents that cannot be adequately pre-medicated * Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically * Imaging evidence or other evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention * Life expectancy of \< 90 days as determined by the investigator * Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study * Female who is pregnant or nursing * Current participation in another investigational drug or device treatment study * Previous enrollment in the eTrieve™ II Study
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pulmonary embolism are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can electronic alerts and patient teaching stop deadly clots after cancer surgery?
- Can a new Five-Category system predict which pulmonary embolism patients will crash?
- A new exercise plan aims to get pulmonary embolism survivors back on their feet
- Spotting hidden blood clots in scarred lungs: a study hunts for clues
- Decades-Long study of 121,700 nurses aims to uncover hidden heart disease triggers
- Massive chest pain registry reveals gaps between guidelines and real-world care in china