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The ArtixASCEND Study

Inari Medical · NCT07135895

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
250
US sites recruiting
23
Study start
January 7, 2026
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Artix Thrombectomy System

Conditions: Acute Lower Limb Arterial Occlusion

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • California Pacific Medical Center Van Ness/Sutter Health

    San Francisco, CA 94109

    Site contact: Hernan Bazan, MD

  • Yale University

    New Haven, CT 06510

    Site contact: Edouard Aboian, MD

  • MedStar Washington Hospital Center

    Washington D.C., DC 20010

    Site contact: Kyle Reynolds, MD

  • Ascension Sacred Heart Pensacola

    Pensacola, FL 32504

    Site contact: Rohit Amin, MD

  • Terrebonne General Hospital/Cardiovascular Institute of the South

    Houma, LA 70360

    Site contact: Pradeep Nair, MD

  • Mass General Hospital

    Boston, MA 02114

    Site contact: Anahita Dua, MD

  • MyMichigan Health

    Midland, MI 48670

    Site contact: Jacob Frisbie, DO

  • Cooper University Hospital

    Camden, NJ 08103

    Site contact: Bruce Tjaden Jr, MD

  • NYP-Brooklyn Methodist Hospital

    Brooklyn, NY 11215

    Site contact: Rajesh K Malik, MD

  • Mount Sinai Medical Center NY

    New York, NY 10025

    Site contact: Michael Dudkiewicz, MD

  • Vassar Brothers Medical Center/Nuvance Health

    Poughkeepsie, NY 12601

    Site contact: Zachary Matthay, MD

  • Stony Brook University Hospital

    Stony Brook, NY 11794

    Site contact: Angela Kokkosis, MD

  • Mission Memorial Hospital

    Asheville, NC 28801

    Site contact: John Henretta, MD

  • Aultman Hospital

    Canton, OH 44710

    Site contact: Jeffrey Prem, MD

  • The Christ Hospital

    Cincinnati, OH 45219

    Site contact: Christopher Paprzycki, MD

  • Ascension St. John Jane Phillips Medical Center

    Bartlesville, OK 74006

    Site contact: Anderson Mehrle, MD

  • Saint Francis Hospital

    Tulsa, OK 74136

    Site contact: Andres Andres Guerra, MD

  • Allegheny General Hospital

    Pittsburgh, PA 15212

    Site contact: Satish Muluk, MD

  • Grand Strand Medical Center

    Myrtle Beach, SC 29572

    Site contact: Christian Salinas, MD

  • Spartanburg Regional Health System

    Spartanburg, SC 29303

    Site contact: Scott Silver, MD

  • TriStar Centennial Medical Center

    Nashville, TN 37203

    Site contact: Allen Lee, MD

  • HCA Houston Healthcare Medical Center

    Houston, TX 77004

    Site contact: Kristofer Charlton-Ouw, MD

  • Bellin Health

    Green Bay, WI 54301

    Site contact: Sumit Ringwala, MD

Study contacts (from the official record)

  • James Allen · 651-279-8587 · james.allen2@stryker.com
  • Chris Ottaviano · 609-634-4571 · chris.ottaviano@stryker.com
The ArtixASCEND Study (NCT07135895) | Bored Studies