Pulmonary EmbolismeTrieve IINCT05821426
Evaluation of the Magneto eTrieve™ PE Kit for Endovascular Thrombectomy in Subjects With Acute Pulmonary Embolism
A study testing eTrieve PE Kit in people with Pulmonary Embolism, run by Magneto Thrombectomy Solutions.
Trial summary
Prospective, multi-center, open-label, single-arm clinical study of the safety and effectiveness of the eTrieve™ in subjects presenting with signs and symptoms of acute intermediate-risk pulmonary embolism Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- eTrieve PE Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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%
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- Any of the following laboratory findings (within 6 hours prior to index procedure):
- Hematocrit < 28%
- Platelets < 100,000/µL
- Serum creatinine > 1.8 mg/dL
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Safety and Effectiveness of Magneto eTrieve™ PE Kit for Endovascular Thrombectomy in Subjects With Acute Pulmonary Embolism
Prospective, multi-center, open-label, single-arm clinical study of the safety and effectiveness of the eTrieve™ in subjects presenting with signs and symptoms of acute intermediate-risk pulmonary embolism
- Conditions
- Pulmonary Embolism
- Being tested
- eTrieve PE Kit
- Keywords
- Pulmonary Embolism, eTrieve
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eTrieve PE KitDevice
Patients will be treated with the eTrieve PE Kit
| Study group | Role | What they receive |
|---|---|---|
| eTrieve PE Kit | Experimental | Not described Receives: Device: eTrieve PE Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAE
Number of Major Adverse Event (MAE) within 48 hours post-index procedure, as adjudicated by the Clinical Events Committee (CEC)
Measured: 48 hours
RV/LV ratio
Change in RV/LV ratio from baseline to 48 hours post-index procedure (or discharge, whichever occurs first) as assessed by the CTA core laboratory
Measured: 48 hours
Secondary outcomes (6)
Use of thrombolytics
Use of thrombolytics within 48 hours post-index procedure
Measured: within 48 hours
ICU/hospitalization length
Length of stay in the Intensive Care Unit (ICU)/hospital, associated with the index thrombectomy procedure
Measured: within 30 days
Modified Miller score
Change in the Modified Miller Score between baseline and 48 hours post-index procedure as assessed by the CTA core laboratory
Measured: at 48 hours
Mortality
Mortality due to any cause within 30 days post-index procedure
Measured: within 30 days
Device related SAE
Device-related serious adverse events within 30 days post-index procedure, as adjudicated by the CEC
Measured: within 30 days
PE reocurrence
Symptomatic PE recurrence within 30 days post-index procedure
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Magneto Thrombectomy Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821426
- Sponsor's protocol ID
- KT1-CLN010
- Acronym
- eTrieve II
- Status last verified
- Sep 2025
- First submitted
- 4 Apr 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of Magneto eTrieve™ PE Kit for Endovascular Thrombectomy in Subjects With Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT05821426
- Acronym / sponsor ID
- eTrieve II / KT1-CLN010
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, eTrieve
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Magneto Thrombectomy SolutionsIndustry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center, open-label, single-arm clinical study of the safety and effectiveness of the eTrieve™ in subjects presenting with signs and symptoms of acute intermediate-risk pulmonary embolism
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eTrieve PE Kit | Experimental | Device: eTrieve PE Kit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eTrieve PE KitPatients will be treated with the eTrieve PE Kit | Device | eTrieve PE Kit |
Primary outcome
MAE
Time frame: 48 hours
Number of Major Adverse Event (MAE) within 48 hours post-index procedure, as adjudicated by the Clinical Events Committee (CEC)
RV/LV ratio
Time frame: 48 hours
Change in RV/LV ratio from baseline to 48 hours post-index procedure (or discharge, whichever occurs first) as assessed by the CTA core laboratory
6 secondary outcomes
Use of thrombolytics
Time frame: within 48 hours
ICU/hospitalization length
Time frame: within 30 days
Modified Miller score
Time frame: at 48 hours
Mortality
Time frame: within 30 days
Device related SAE
Time frame: within 30 days
PE reocurrence
Time frame: within 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing eTrieve PE Kit in people with Pulmonary Embolism, run by Magneto Thrombectomy Solutions.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tami Abudi (+972 (52) 5989833, tami@magts.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAE (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.