Artix Thrombectomy System for acute lower limb arterial occlusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This post-market, prospective, multicenter, single-arm study enrolls adults with acute lower extremity arterial occlusions treated with the Artix Thrombectomy System. Participants must have symptom duration ≤14 days, a target native vessel 3–8 mm in diameter below the inguinal ligament, and Rutherford category I–IIb ischemia. The Artix device is used as the primary endovascular method for clot removal, with clinicians following local standards for adjunctive treatments and follow-up. Outcomes focus on device safety and technical and clinical effectiveness, including revascularization and limb-related clinical endpoints.

Why it matters

Who can join: the full rules

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

Where it's running

• California Pacific Medical Center Van Ness/Sutter Health
  San Francisco, California, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• MedStar Washington Hospital Center
  Washington D.C., District of Columbia, United States Recruiting
• Ascension Sacred Heart Pensacola
  Pensacola, Florida, United States Recruiting
• Terrebonne General Hospital/Cardiovascular Institute of the South
  Houma, Louisiana, United States Recruiting
• University of Maryland Medical Center
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Anahita Dua, MD — Massachusetts General Hospital
• Study coordinator: James Allen
• Email: james.allen2@stryker.com
• Phone: 651-279-8587

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.