Aventus Thrombectomy System Pulmonary Embolism Clinical Study
NCT ID: NCT05907564
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2023-09-20
2025-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
Device: Aventus Thrombectomy System
Thrombectomy
Use of Aventus Thrombectomy System to treat pulmonary embolism
Interventions
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Thrombectomy
Use of Aventus Thrombectomy System to treat pulmonary embolism
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
80 Years
ALL
No
Sponsors
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Inquis Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jun Li, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals
Saher Sabri, MD
Role: PRINCIPAL_INVESTIGATOR
MedStar Health
Locations
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Honor Health
Scottsdale, Arizona, United States
NorthBay Medical Center
Fairfield, California, United States
MemorialCare
Long Beach, California, United States
El Camino Health
Mountain View, California, United States
Sutter Health
Sacramento, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Medstar
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Ascension St. Vincent
Indianapolis, Indiana, United States
Ochsner Health
New Orleans, Louisiana, United States
McLaren Health Care
Bay City, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Ascension Providence
Southfield, Michigan, United States
CentraCare Heart and Vascular
Saint Cloud, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Ichan School of Medicine at Mount Sinai
New York, New York, United States
University Hospitals
Cleveland, Ohio, United States
OhioHealth Research Institute
Columbus, Ohio, United States
ProMedica - Jobst Vascular
Toledo, Ohio, United States
Ascension St. John
Tulsa, Oklahoma, United States
The Miriam Hospital
Providence, Rhode Island, United States
Centennial Medical Center (HCA)
Nashville, Tennessee, United States
Ascension Seton
Austin, Texas, United States
Countries
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Other Identifiers
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CT-0001
Identifier Type: -
Identifier Source: org_study_id
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