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Aventus Thrombectomy System Pulmonary Embolism Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05907564
Recruitment Status : Recruiting
First Posted : June 18, 2023
Last Update Posted : April 4, 2024
Sponsor:
Information provided by (Responsible Party):
Inquis Medical, Inc.

Study Description
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Brief Summary:
Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Embolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Device: Thrombectomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluate the Safety and Efficacy of the Aventus Thrombectomy System for Aspiration Thrombectomy in Subjects With Acute Pulmonary Embolism
Actual Study Start Date : September 20, 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Arm
Device: Aventus Thrombectomy System
 Device: Thrombectomy
Use of Aventus Thrombectomy System to treat pulmonary embolism


Outcome Measures
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Primary Outcome Measures :
  1. Change in RV/LV Ratio [ Time Frame: From Baseline to 48 hours ]
    Change in RV/LV Ratio per CTA

  2. Major Adverse Event Rate [ Time Frame: From Index Procedure to 48 hours ]
    Composite of device related MAEs including death, major bleed, clinical deterioration, pulmonary vascular injury, and cardiac injury


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05907564


Contacts
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Contact: Marc Penna 978-760-0311 clinical@inquismedical.com

Locations
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United States, Arizona
Honor Health Recruiting
Scottsdale, Arizona, United States, 85258
United States, California
MemorialCare Recruiting
Long Beach, California, United States, 90806
United States, District of Columbia
Medstar Recruiting
Washington, District of Columbia, United States, 20010
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Alexian Brothers Medical Center Recruiting
Elk Grove Village, Illinois, United States, 60007
United States, Indiana
Ascension St. Vincent Recruiting
Indianapolis, Indiana, United States, 46260
United States, Michigan
Ascension Providence Recruiting
Southfield, Michigan, United States, 48075
United States, Minnesota
CentraCare Heart and Vascular Recruiting
Saint Cloud, Minnesota, United States, 56303
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Holy Name Medical Center Recruiting
Teaneck, New Jersey, United States, 07666
United States, Ohio
University Hospitals Recruiting
Cleveland, Ohio, United States, 44106
OhioHealth Research Institute Recruiting
Columbus, Ohio, United States, 43214
ProMedica - Jobst Vascular Recruiting
Toledo, Ohio, United States, 43606
United States, Oklahoma
Ascension St. John Recruiting
Tulsa, Oklahoma, United States, 74006
United States, Tennessee
Centennial Medical Center (HCA) Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Ascension Seton Recruiting
Austin, Texas, United States, 78705
Sponsors and Collaborators
Inquis Medical, Inc.
Investigators
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Principal Investigator: Jun Li, MD University Hospitals
Principal Investigator: Saher Sabri, MD MedStar Health
More Information
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Responsible Party: Inquis Medical, Inc.
ClinicalTrials.gov Identifier: NCT05907564    
Other Study ID Numbers: CT-0001
First Posted: June 18, 2023    Key Record Dates
Last Update Posted: April 4, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Inquis Medical, Inc.:
Pulmonary Embolism
Clot
Thromboembolism
Thrombectomy
Right Heart Strain
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Embolism
Respiratory Tract Diseases
Cardiovascular Diseases
 Thrombosis
Embolism
Vascular Diseases
Embolism and Thrombosis