Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
250 participants
INTERVENTIONAL
2025-12-31
2029-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Artix Thrombectomy System
Non-surgical removal of lower extremity arterial emboli and thrombi using the Artix Thrombectomy System.
Artix Thrombectomy System
Treatment of lower extremity arterial occlusions using the Artix Thrombectomy System.
Interventions
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Artix Thrombectomy System
Treatment of lower extremity arterial occlusions using the Artix Thrombectomy System.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Inari Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Ashleigh Willson
Role: STUDY_DIRECTOR
Inari Medical
Central Contacts
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Other Identifiers
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25-001
Identifier Type: -
Identifier Source: org_study_id