Aventus Thrombectomy System Pulmonary Embolism Clinical Study

April 3, 2024 updated by: Inquis Medical, Inc.

Evaluate the Safety and Efficacy of the Aventus Thrombectomy System for Aspiration Thrombectomy in Subjects With Acute Pulmonary Embolism

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Honor Health
    • California
      • Long Beach, California, United States, 90806
        • Recruiting
        • MemorialCare
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Shavelle, MD
        • Sub-Investigator:
          • Khiet Hoang, MD
        • Sub-Investigator:
          • Aditya Prasad, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Medstar
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Sub-Investigator:
          • James Flaherty, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dan Schimmel, MD
        • Sub-Investigator:
          • Keith Benzuly, MD
      • Elk Grove Village, Illinois, United States, 60007
        • Recruiting
        • Alexian Brothers Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Ascension St. Vincent
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Recruiting
        • Ascension Providence
    • Minnesota
      • Saint Cloud, Minnesota, United States, 56303
        • Recruiting
        • Centracare Heart and Vascular
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
      • Teaneck, New Jersey, United States, 07666
        • Recruiting
        • Holy Name Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals
        • Principal Investigator:
          • Jun Li, MD
        • Sub-Investigator:
          • Tarek Hammad, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yulanka Castro-Dominguez, MD
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • OhioHealth Research Institute
        • Sub-Investigator:
          • Joseph Campbell, MD
        • Sub-Investigator:
          • Christopher Huff, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Jolly, MD
        • Sub-Investigator:
          • John Philips, MD
      • Toledo, Ohio, United States, 43606
        • Recruiting
        • ProMedica - Jobst Vascular
        • Sub-Investigator:
          • Jihad Abbas, MD
        • Sub-Investigator:
          • Brett Aplin, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ahmad Younes, MD
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74006
        • Recruiting
        • Ascension St. John
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Centennial Medical Center (HCA)
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Ascension Seton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Device: Aventus Thrombectomy System
Device: Thrombectomy
Use of Aventus Thrombectomy System to treat pulmonary embolism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in RV/LV Ratio
Time Frame: From Baseline to 48 hours
Change in RV/LV Ratio per CTA
From Baseline to 48 hours
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
From Index Procedure to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inquis Medical, Inc.

Investigators

  • Principal Investigator: Jun Li, MD, University Hospitals
  • Principal Investigator: Saher Sabri, MD, MedStar Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

June 8, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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