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Recruiting NCT07135895

The ArtixASCEND Study

No phase Interventional Acute Lower Limb Arterial Occlusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Artix Thrombectomy System.
Who it may be relevant to
Registry conditions: Acute Lower Limb Arterial Occlusion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Artix All-in-one Solution for Complete thrombEctomy With eNDovascular Approach

Overview

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.

Interventions

  • Device Artix Thrombectomy System
    Treatment of lower extremity arterial occlusions using the Artix Thrombectomy System.

Primary outcome measures

  • Primary Effectiveness Endpoint [Time frame: Immediately Following Index Procedure]
  • Primary Safety Endpoint [Time frame: 48 Hours]
Secondary outcome measures (4)
  • Distal embolization SAEs [Time frame: Intra-procedure]
  • All-cause mortality [Time frame: 1-month follow-up visit]
  • Limb salvage [Time frame: 1-month follow-up visit]
  • Amputation-free survival [Time frame: 1-month follow-up visit]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 20 centers
  • California Pacific Medical Center Van Ness/Sutter Health — San Francisco
  • Yale University — New Haven
  • MedStar Washington Hospital Center — Washington D.C.
  • Ascension Sacred Heart Pensacola — Pensacola
  • Terrebonne General Hospital/Cardiovascular Institute of the South — Houma
  • Mass General Hospital — Boston
  • MyMichigan Health — Midland
  • Cooper University Hospital — Camden
  • … and 12 more centers

Identifiers

NCT: NCT07135895 · 25-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗