The ArtixASCEND Study (NCT07135895) | Clinical Trial Compass
RecruitingNot Applicable
The ArtixASCEND Study
United States250 participantsStarted 2026-01-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 subje…