The ArtixASCEND Study

Last updated: September 21, 2026
Sponsor: Inari Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Artix Thrombectomy System

Clinical Study ID

NCT07135895
25-001
  • Ages > 18
  • All Genders

Study Summary

This study is a post-market, prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Acute symptom duration ≤ 14 days

  • Lower limb arterial occlusion below inguinal ligament

  • Target lesion in native vessel

  • Target vessel size between 3 mm and 8 mm by visual estimation

  • Rutherford category I, IIa, or IIb

  • Informed consent is obtained from either patient or legally authorizedrepresentative (LAR) per Institutional Review Board/Ethics Committee requirements

Exclusion

Exclusion Criteria:

  • Life expectancy < 6 months

  • Prior major amputation in the target limb

  • Prior minor amputation in the target limb that is not completely healed or cannotbear weight

  • Non-thrombotic occlusion secondary to dissection, vasculitis, or target vesseltrauma

  • Treatment of the index event in the target vessel with any other endovascularthrombectomy/aspiration or open surgical method prior to Artix procedure

  • Part of a vulnerable population (e.g., currently pregnant, breastfeeding orincarcerated) per local definitions

  • Known sensitivity to radiographic contrast agents that, in the Investigator'sopinion, cannot be adequately pre-treated

  • Unable to tolerate antiplatelet therapy

  • Inability to anticoagulate the patient with heparin, enoxaparin or other parenteralantithrombin, or known to have uncorrected bleeding disorders (e.g.,gastro-intestinal ulcer, menorrhagia, liver failure, heparin-inducedthrombocytopenia (HIT))

  • Any condition for which, in the opinion of the Investigator, participation would notbe in the best interest of the subject (e.g., contraindication to use of Artix perlocal approved labeling, compromise the well-being or that could prevent, limit, orconfound the protocol-specified assessments)

  • Current participation in another drug or device study that, in the investigator'sopinion, would interfere with participation in this study

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Artix Thrombectomy System
Phase:
Study Start date:
January 07, 2026
Estimated Completion Date:
October 01, 2029

Connect with a study center

  • California Pacific Medical Center Van Ness/Sutter Health

    San Francisco, California 94109
    United States

    Active - Recruiting

  • Yale University

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia 20010
    United States

    Active - Recruiting

  • Ascension Sacred Heart Pensacola

    Pensacola, Florida 32504
    United States

    Active - Recruiting

  • Terrebonne General Hospital/Cardiovascular Institute of the South

    Houma, Louisiana 70360
    United States

    Active - Recruiting

  • Mass General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • MyMichigan Health

    Midland, Michigan 48670
    United States

    Active - Recruiting

  • Cooper University Hospital

    Camden, New Jersey 08103
    United States

    Active - Recruiting

  • NYP-Brooklyn Methodist Hospital

    Brooklyn, New York 11215
    United States

    Active - Recruiting

  • Vassar Brothers Medical Center/Nuvance Health

    Poughkeepsie, New York 12601
    United States

    Active - Recruiting

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Active - Recruiting

  • Mission Memorial Hospital

    Asheville, North Carolina 28801
    United States

    Active - Recruiting

  • Aultman Hospital

    Canton, Ohio 44710
    United States

    Active - Recruiting

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Ascension St. John Jane Phillips Medical Center

    Bartlesville, Oklahoma 74006
    United States

    Active - Recruiting

  • Saint Francis Hospital

    Tulsa, Oklahoma 74136
    United States

    Active - Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Grand Strand Medical Center

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • Spartanburg Regional Health System

    Spartanburg, South Carolina 29303
    United States

    Active - Recruiting

  • TriStar Centennial Medical Center

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • HCA Houston Healthcare Medical Center

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Bellin Health

    Green Bay, Wisconsin 54301
    United States

    Active - Recruiting

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