An interventional study of Vertex Pulmonary Embolectomy System in Pulmonary Embolism, sponsored by Neptune Medical. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Neptune Medical · Not applicable, Interventional, and Treatment
This study study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of pulmonary embolism.
The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of acute pulmonary embolism.
The Vertex Pulmonary Embolectomy System is intended for the non-surgical removal of emboli and thrombi from blood vessels as a means for treating pulmonary embolism.
832 studies on the registry are indexed under Pulmonary Embolism; 171 are open to participants now.
This study's enrollment of 10 is below the median of 174 across 429 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Neptune Medical is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients presenting with clinical signs and symptoms of acute pulmonary embolism and who meet the study criteria will be treated with the Vertex Pulmonary Embolectomy System
Device: Vertex Pulmonary Embolectomy System
Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.
Change in Right Ventricle/Left Ventricle (RV/LV) Ratio
The RV/LV diameter ratio is defined as the ratio of the maximal right ventricle (RV) to left ventricle (LV) diameters measured on computed tomography (CT) pulmonary angiography images. Measurements are performed by an independent core laboratory using standardized axial CT images, with ventricular diameters measured at the widest point of each ventricle. Change in RV/LV ratio is calculated for each participant as the difference between the value obtained at baseline (pre-procedure) and the value obtained at 48 hours post-procedure or at hospital discharge, whichever occurs first. A reduction in RV/LV ratio indicates improvement in right ventricular dilatation.
Time frame: From baseline to 48 hours or discharge
Major Adverse Events (MAEs)
A composite of: Device-related death within 48 hours Major bleeding within 48 hours Device-related AEs within 48 hours, including: * Clinical deterioration * Pulmonary vascular injury * Cardiac injury
Time frame: Within 48 hours of procedure
| Milestone | Vertex Pulmonary Embolectomy System |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
The RV/LV diameter ratio is defined as the ratio of the maximal right ventricle (RV) to left ventricle (LV) diameters measured on computed tomography (CT) pulmonary angiography images. Measurements are performed by an independent core laboratory using standardized axial CT images, with ventricular diameters measured at the widest point of each ventricle. Change in RV/LV ratio is calculated for each participant as the difference between the value obtained at baseline (pre-procedure) and the value obtained at 48 hours post-procedure or at hospital discharge, whichever occurs first. A reduction in RV/LV ratio indicates improvement in right ventricular dilatation.
| Ratio | Vertex Pulmonary Embolectomy System |
|---|---|
| Change in Right Ventricle/Left Ventricle (RV/LV) Ratio | -0.4 ± 0.3 |
A composite of: Device-related death within 48 hours Major bleeding within 48 hours Device-related AEs within 48 hours, including: * Clinical deterioration * Pulmonary vascular injury * Cardiac injury
| Participants | Vertex Pulmonary Embolectomy System |
|---|---|
| Participants with ≥1 MAE | 0 |
| Participants without any MAE | 10 |
Collected over From procedure through 30 days (± 3 days) post-procedure, including the primary safety window of 48 hours (± 8 hours). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vertex Pulmonary Embolectomy System | 0/10 (0%) | 1/10 (10%) | 3/10 (30%) |
| Event | Vertex Pulmonary Embolectomy System |
|---|---|
| Drop in hemoglobinBlood and lymphatic system disorders | 1/10 |
| Event | Vertex Pulmonary Embolectomy System |
|---|---|
| Kidney injuryRenal and urinary disorders | 1/10 |
| Inguinal hematomaInjury, poisoning and procedural complications | 1/10 |
| Drop in hemoglobinBlood and lymphatic system disorders | 1/10 |
| PneumoniaInfections and infestations | 1/10 |
| Age, Continuous(years) | Vertex Pulmonary Embolectomy System |
|---|---|
| Mean | 67.2 ± 6.5 |
| Sex: Female, Male(Participants) | Vertex Pulmonary Embolectomy System |
|---|---|
| Female | 6 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Vertex Pulmonary Embolectomy System |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Vertex Pulmonary Embolectomy System |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Vertex Pulmonary Embolectomy System |
|---|---|
| Austria | 5 |
| Poland | 5 |
| Modified Medical Research Council (mMRC) Dyspnea Scale(Participants) | Vertex Pulmonary Embolectomy System |
|---|---|
| Grade 0 | 0 |
| Grade 1 | 0 |
| Grade 2 | 1 |
| Grade 3 | 4 |
| Grade 4 | 5 |
| Injury severity score (ISS)(Participants) | Vertex Pulmonary Embolectomy System |
|---|---|
| ISS <15 (study eligibility criterion) | 10 |
| ISS ≥15 | 0 |
| Serum Creatinine(Participants) | Vertex Pulmonary Embolectomy System |
|---|---|
| Serum baseline creatinine ≤ 1.8 mg/dL (eligibility criterion) | 10 |
| Serum baseline creatinine > 1.8 mg/dL | 0 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Will not be sharing IPD.
Ran from Sep 2024 to primary completion in Apr 2025, 7 months.
Results were first posted in May 2026, 1 year after primary completion.
Of 150 interventional studies with no phase under Pulmonary Embolism, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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