The ArtixASCEND Study

Inari Medical

Status: Not yet enrolling

Conditions: Acute Lower Limb Arterial Occlusion

Treatments: Device: Artix Thrombectomy System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07135895

25-001

Details and patient eligibility

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Artix Thrombectomy System

Experimental group

Description:

Non-surgical removal of lower extremity arterial emboli and thrombi using the Artix Thrombectomy System.

Treatment:

Device: Artix Thrombectomy System