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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05907564
Other study ID # CT-0001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 20, 2023
Est. completion date March 2025

Study information

Verified date April 2024
Source Inquis Medical, Inc.
Contact Marc Penna
Phone 978-760-0311
Email clinical@inquismedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 symptom(s) duration = 14 days from index procedure 5. PE diagnosis = 48 hours prior to index procedure 6. CTA 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 with an RV/LV ratio of = 0.9 at baseline based on Investigator determination 8. Systolic blood pressure = 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)

Study Design


Intervention

Device:
Thrombectomy
Use of Aventus Thrombectomy System to treat pulmonary embolism

Locations

Country Name City State
United States Ascension Seton Austin Texas
United States Northwestern University Chicago Illinois
United States University Hospitals Cleveland Ohio
United States OhioHealth Research Institute Columbus Ohio
United States Alexian Brothers Medical Center Elk Grove Village Illinois
United States Hackensack University Medical Center Hackensack New Jersey
United States Ascension St. Vincent Indianapolis Indiana
United States MemorialCare Long Beach California
United States Centennial Medical Center (HCA) Nashville Tennessee
United States CentraCare Heart and Vascular Saint Cloud Minnesota
United States Honor Health Scottsdale Arizona
United States Ascension Providence Southfield Michigan
United States Holy Name Medical Center Teaneck New Jersey
United States ProMedica - Jobst Vascular Toledo Ohio
United States Ascension St. John Tulsa Oklahoma
United States Medstar Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Inquis Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in RV/LV Ratio Change in RV/LV Ratio per CTA From Baseline to 48 hours
Primary Major Adverse Event Rate Composite of device related MAEs including death, major bleed, clinical deterioration, pulmonary vascular injury, and cardiac injury From Index Procedure to 48 hours
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