The ArtixASCEND Study

Recruiting now · Not applicable

Conditions studied: Acute Lower Limb Arterial Occlusion

In brief

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.

Key facts

Study ID

NCT07135895

Run by

Inari Medical

People needed

250

Starts

2026-01-07

Expected to finish

2029-10-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• California Pacific Medical Center Van Ness/Sutter Health — San Francisco, California, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• Ascension Sacred Heart Pensacola — Pensacola, Florida, United States (enrolling)
• Terrebonne General Hospital/Cardiovascular Institute of the South — Houma, Louisiana, United States (enrolling)
• Mass General Hospital — Boston, Massachusetts, United States (enrolling)
• MyMichigan Health — Midland, Michigan, United States (enrolling)
• Cooper University Hospital — Camden, New Jersey, United States (enrolling)
• NYP-Brooklyn Methodist Hospital — Brooklyn, New York, United States (enrolling)
• Vassar Brothers Medical Center/Nuvance Health — Poughkeepsie, New York, United States (enrolling)
• Mission Memorial Hospital — Asheville, North Carolina, United States (enrolling)
• Aultman Hospital — Canton, Ohio, United States (enrolling)
• The Christ Hospital — Cincinnati, Ohio, United States (enrolling)
• Ascension St. John Jane Phillips Medical Center — Bartlesville, Oklahoma, United States (enrolling)
• Saint Francis Hospital — Tulsa, Oklahoma, United States (enrolling)
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
• Grand Strand Medical Center — Myrtle Beach, South Carolina, United States (enrolling)
• Spartanburg Regional Health System — Spartanburg, South Carolina, United States (enrolling)
• TriStar Centennial Medical Center — Nashville, Tennessee, United States (enrolling)
• Bellin Health — Green Bay, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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