Artix Thrombectomy System: Treatment of lower extremity arterial occlusions using the Artix Thrombectomy System.
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Primary Effectiveness Endpoint — Immediately Following Index Procedure Revascularization rate post-index procedure of target treatment area determined by an independent core lab.
Primary Safety Endpoint — 48 Hours Periprocedural (within 48 hours) Artix Thrombectomy System-related major bleeding rate adjudicated as causal to the study device as determined by an independent Medical Monitor.
Trial sites (20)
Facility
City
Region
Status
California Pacific Medical Center Van Ness/Sutter Health
San Francisco
California
Recruiting
Yale University
New Haven
Connecticut
Recruiting
MedStar Washington Hospital Center
Washington D.C.
District of Columbia
Recruiting
Ascension Sacred Heart Pensacola
Pensacola
Florida
Recruiting
Terrebonne General Hospital/Cardiovascular Institute of the South
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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