Cardiovascular Diseases, Embolism, Embolism and Thrombosis, Lung Diseases, Pulmonary Embolism, Respiratory Tract Diseases, Vascular Diseases
Conditions
Keywords
Pulmonary Embolism, Clot, Thromboembolism, Thrombectomy, Right Heart Strain
Brief summary
Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.
Interventions
DEVICEThrombectomy
Use of Aventus Thrombectomy System to treat pulmonary embolism
Sponsors
Inquis Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 and ≤ 80 years 2. 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 3. Subject is willing and able to comply with all protocol required follow-up visits 4. PE (pulmonary embolism) symptom(s) duration ≤ 14 days from index procedure 5. PE diagnosis ≤ 48 hours prior to index procedure 6. CTA (computed tomography angiography) evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery based on Investigator determination) 7. CTA evidence of dilated RV (right ventricle) with an RV/LV (left ventricle) ratio of ≥ 0.9 at baseline based on Investigator determination 8. Systolic blood pressure (SBP) ≥ 90 mmHg without need for vasopressors (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with intravenous fluids prior to index procedure) 9. Stable heart rate \< 130 BPM prior to index procedure 10. Subject is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment
Exclusion criteria
1. Prior PE ≤ 180 days from index procedure 2. Current hospitalization for other condition(s) 3. Thrombolytic use ≤ 14 days of baseline CTA 4. Pulmonary hypertension with peak pulmonary artery systolic pressure \> 70 mmHg by right heart catheterization 5. FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90% 6. Hematocrit \< 28% within 6 hours of index procedure 7. Platelets \< 100,000/μL 8. Serum creatinine \> 1.8 mg/dL 9. International normalized ratio (INR) \> 3 10. Presence of intracardiac lead in the right ventricle or right atrium placed \< 180 days prior to index procedure 11. Cardiovascular or pulmonary surgery ≤ 7 days prior to 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 uncompensated 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. Any contraindication to systemic or therapeutic doses of heparin or anticoagulants 22. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated 23. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for aspiration thrombectomy intervention such as the inability to navigate to target location, predominantly chronic clot or non-clot embolus 24. Life expectancy of \< 90 days, as determined by Investigator 25. Female who is pregnant or nursing 26. Current participation in another investigational drug or device treatment study that has not reached the primary endpoint or the Investigator feels would impact their ability to participate in this clinical trial 27. Subject has known residual Iliac Deep Vein Thrombosis (DVT), Inferior Vena Cava (IVC) clot or clot in transit (right atrium and/or right ventricular) 28. Subject on extracorporeal membrane oxygenation (ECMO)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in RV/LV Ratio | at 48hrs compared to baseline | Mean Change in RV (right ventricle)/LV(left ventricle) Ratio at 48hrs compared to baseline |
| Device Related Major Adverse Event Rate | From Index Procedure to 48 hours | Composite of device related MAEs (major adverse events) including death, major bleed, clinical deterioration, pulmonary vascular injury, and cardiac injury |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWissam Jaber, MD
Emory University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 45 Participants |
| Age, Categorical Between 18 and 65 years | 75 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 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 | 20 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 | 7 Participants |
| Race (NIH/OMB) White | 93 Participants |
| Region of Enrollment United States | 120 Participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 120 |
| other Total, other adverse events | 40 / 120 |
| serious Total, serious adverse events | 10 / 120 |
Outcome results
None listed