NCT07135895 · Inari Medical
The ArtixASCEND Study
What this study is about
This study is a post-market, forward-looking, conducted at multiple hospitals, single-treatment group$1 study to evaluate the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New Haven, Connecticut
- Washington D.C., District of Columbia
- Boston, Massachusetts
- Midland, Michigan
- Camden, New Jersey
- Asheville, North Carolina
- Canton, Ohio
- Cincinnati, Ohio
- Bartlesville, Oklahoma
- Tulsa, Oklahoma
- Pittsburgh, Pennsylvania
- Myrtle Beach, South Carolina
And 2 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations