Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication

Last updated: November 27, 2024
Sponsor: Endologix
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Heart Disease

Aneurysm

Cardiovascular Disease

Treatment

Chimney Endovascular Aortic Sealing (ChEVAS) System

Clinical Study ID

NCT04252573
CP-0015
  • Ages > 18
  • All Genders

Study Summary

Prospective, multi-center, non-randomized study with consecutive, eligible subject enrollment at each site, for the evaluation of the ChEVAS System for Endovascular Repair of Complex Abdominal Aortic Aneurysms.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults at least 18-years old

  • Subject provided informed consent

  • Subject agrees to all follow-up visits

  • Abdominal aortic aneurysm (AAA) with maximum sac diameter ≥5.0 cm, or ≥ 4.5 cm whichhas increased by ≥ 0.5cm within the last 6-months, or which exceeds 1.5 times thetransverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4cm willbe included

  • Absence of significant cranial angulation of the visceral vessels that wouldpreclude vessel cannulation and stenting

Exclusion

Exclusion Criteria:

  • Requirement of home oxygen

  • Psychiatric or other condition that may interfere with the study

  • Participating in another clinical drug and/or device study, which could confound theresults of this study (patient must have completed the primary endpoint of anyprevious study at least 30-days prior to enrollment in this study)

  • Known allergy or contraindication to any device material, contrast, oranticoagulants

  • Serum creatinine level >1.8mg/dL

  • CVA or MI within three months of enrollment/treatment

  • Prior stent in any target visceral vessel, the aorta or iliac artery that mayinterfere with delivery system introduction or stent placement

  • Connective tissue diseases (e.g., Marfan Syndrome)

  • Unsuitable vascular anatomy that may interfere with device introduction ordeployment

  • Pregnant, planning to become pregnant within 60 months, or breast feeding.

Study Design

Total Participants: 13
Treatment Group(s): 1
Primary Treatment: Chimney Endovascular Aortic Sealing (ChEVAS) System
Phase:
Study Start date:
June 29, 2020
Estimated Completion Date:
March 31, 2028

Study Description

This is a prospective multicenter study with consecutive eligible subject enrollment at each site. Enrollment will include up to 150 subjects (120 ChEVAS subjects and up to 30 infrarenal roll-in subjects). The ChEVAS study will evaluate the safety and effectiveness outcomes following appropriate government and ethics committee/IRB requirements and guidelines.

All enrolled (ChEVAS and Infrarenal) subjects will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30-days, 6-months, and annually to 5-years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.

*As of October 27, 2021 ChEVAS ONE Study is voluntarily closed to screening and consenting. 13 subjects enrolled in the study will continue to be observed through 5-years.

Connect with a study center

  • Valley Vascular Consultants

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Phoenix Cardiovascular Research

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • VA San Diego Healthcare System

    La Jolla, California 92037
    United States

    Site Not Available

  • Regents of the University of California (UCLA)

    Los Angeles, California 90095
    United States

    Site Not Available

  • UC Health- Memorial Hospital

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • MedStar Health Research Institute

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Baptist Hospital of Miami

    Miami, Florida 33176
    United States

    Site Not Available

  • Advent Health Orlando

    Orlando, Florida 32803
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • St Vincent Medical Group

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • McLaren Bay Region

    Bay City, Michigan 48708
    United States

    Site Not Available

  • University of Missouri

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Midwest Aortic & Vascular Institute (MAVI)

    North Kansas City, Missouri 64116
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03766
    United States

    Site Not Available

  • Cooper University Hospital

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10019
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Providence Portland

    Portland, Oregon 97213
    United States

    Site Not Available

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Wellmont CVA Heart Institute

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Cardiovascular Surgery Clinic

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Inova Fairfax

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Sentara Vascular Specialists

    Norfolk, Virginia 23507
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.