Pulmonary Embolism
Conditions
Keywords
Embolism and Thrombosis, Pulmonary Embolism, Embolism, Cardiovascular Diseases
Brief summary
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.
Detailed description
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.
Interventions
Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.
Sponsors
Neptune Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years \< 80 years 2. Acute onset of symptoms ≤ 14 days consistent with the presence of pulmonary embolism. 3. CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery) 4. RV/LV ratio of \> 0.9 on CTA as assessed by investigator (site determined). 5. Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids) 6. Subject is willing and able to provide written informed consent prior to receiving any non-standard of care clinical investigation plan specific procedures 7. Subject is willing and able to comply with all clinical investigation plan required follow-up visits
Exclusion criteria
1. Thrombolytic use within 30 days of baseline CTA 2. Pulmonary hypertension with peak pulmonary artery pressure \> 70 mmHg by right heart catheterization (site determined) 3. Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg 4. Unstable heart rate \> 130 beats per minute prior to procedure 5. FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90% 6. Hematocrit \< 28% 7. Platelets \< 100,000/µL 8. Serum baseline creatinine \> 1.8 mg/dL 9. International normalized ratio (INR) \> 3 10. Major trauma injury severity score (ISS) \> 15 within the past 14 days 11. Presence of intracardiac lead in the right ventricle or right atrium placed \<180 days prior to the index procedure 12. Cardiovascular or pulmonary surgery within last 30 days 13. Actively progressing cancer requiring chemotherapy 14. Known bleeding diathesis or coagulation disorder 15. Left bundle branch block 16. History of severe or chronic pulmonary arterial hypertension 17. History of chronic left heart disease with left ventricular ejection fraction ≤ 30% 18. History of decompensated heart failure 19. Patients on extracorporeal membrane oxygenation (ECMO) 20. History of underlying lung disease that is oxygen dependent 21. History of chest irradiation 22. History of heparin-induced thrombocytopenia (HIT) 23. Contraindication to systemic or therapeutic doses of heparin or anticoagulants 24. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated 25. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention 26. Life expectancy of \< 365 days, as determined by Investigator 27. Female who is pregnant or nursing 28. Current participation in another investigational drug or device treatment study 29. Inability to lay flat for procedure 30. Known presence of right-to-left cardiac shunt 31. History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days 32. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Right Ventricle/Left Ventricle (RV/LV) Ratio | From baseline to 48 hours or discharge | 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. |
| Major Adverse Events (MAEs) | Within 48 hours of procedure | 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 |
Countries
Austria, Poland
Contacts
STUDY_DIRECTORAadi Chachad
Sponsor GmbH
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 6.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Injury severity score (ISS) ISS ≥15 | 0 Participants |
| Injury severity score (ISS) ISS <15 (study eligibility criterion) | 10 Participants |
| INR INR ≤ 3 | 10 Participants |
| INR INR > 3 | 0 Participants |
| Modified Medical Research Council (mMRC) Dyspnea Scale Grade 0 | 0 Participants |
| Modified Medical Research Council (mMRC) Dyspnea Scale Grade 1 | 0 Participants |
| Modified Medical Research Council (mMRC) Dyspnea Scale Grade 2 | 1 Participants |
| Modified Medical Research Council (mMRC) Dyspnea Scale Grade 3 | 4 Participants |
| Modified Medical Research Council (mMRC) Dyspnea Scale Grade 4 | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment Austria | 5 participants |
| Region of Enrollment Poland | 5 participants |
| Serum Creatinine Serum baseline creatinine > 1.8 mg/dL | 0 Participants |
| Serum Creatinine Serum baseline creatinine ≤ 1.8 mg/dL (eligibility criterion) | 10 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 3 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
None listed