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NCT07135895NARecruiting

The ArtixASCEND Study

Inari Medical

Start Date

1/7/2026

Completion Date

10/1/2029

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

Age Range: 18 years to No maximum

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 authorized representative (LAR) per Institutional Review Board/Ethics Committee requirements 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 cannot bear weight * Non-thrombotic occlusion secondary to dissection, vasculitis, or target vessel trauma * Treatment of the index event in the target vessel with any other endovascular thrombectomy/aspiration or open surgical method prior to Artix procedure * Part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions * Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated * Unable to tolerate antiplatelet therapy * Inability to anticoagulate the patient with heparin, enoxaparin or other parenteral antithrombin, or known to have uncorrected bleeding disorders (e.g., gastro-intestinal ulcer, menorrhagia, liver failure, heparin-induced thrombocytopenia (HIT)) * Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject (e.g., contraindication to use of Artix per local approved labeling, compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments) * Current participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this study

Interventions

DEVICE

Artix Thrombectomy System

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Conditions

Acute Lower Limb Arterial Occlusion

Locations

Yale University

New Haven, Connecticut 06510

United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia 20010

United States

Ascension Sacred Heart Pensacola

Pensacola, Florida 32504

United States

Terrebonne General Hospital/Cardiovascular Institute of the South

Houma, Louisiana 70360

United States

Mass General Hospital

Boston, Massachusetts 02114

United States

MyMichigan Health

Midland, Michigan 48670

United States

Cooper University Hospital

Camden, New Jersey 08103

United States

Mission Memorial Hospital

Asheville, North Carolina 28801

United States

Aultman Hospital

Canton, Ohio 44710

United States

The Christ Hospital

Cincinnati, Ohio 45219

United States

Ascension St. John Jane Phillips Medical Center

Bartlesville, Oklahoma 74006

United States

Saint Francis Hospital

Tulsa, Oklahoma 74136

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania 15212

United States

Grand Strand Medical Center

Myrtle Beach, South Carolina 29572

United States

Spartanburg Regional Health System

Spartanburg, South Carolina 29303

United States

TriStar Centennial Medical Center

Nashville, Tennessee 37203

United States

Bellin Health

Green Bay, Wisconsin 54301

United States