NCT07135895From ClinicalTrials.govRecruiting

The ArtixASCEND Study

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

Acute Lower Limb Arterial Occlusion

At a glance

Phase: Phase not stated
Study type: Interventional
Sponsor: Inari Medical
Enrolment target: 250
Started: 7 January 2026
Main results due: 1 March 2029
Study sites: 22
Registry updated: 23 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(22)

California Pacific Medical Center Van Ness/Sutter Health
San Francisco, California, United States
Recruiting
Yale University
New Haven, Connecticut, United States
Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Recruiting
Ascension Sacred Heart Pensacola
Pensacola, Florida, United States
Recruiting
Terrebonne General Hospital/Cardiovascular Institute of the South
Houma, Louisiana, United States
Recruiting
Mass General Hospital
Boston, Massachusetts, United States
Recruiting
MyMichigan Health
Midland, Michigan, United States
Recruiting
Cooper University Hospital
Camden, New Jersey, United States
Recruiting
NYP-Brooklyn Methodist Hospital
Brooklyn, New York, United States
Recruiting
Vassar Brothers Medical Center/Nuvance Health
Poughkeepsie, New York, United States
Recruiting
Stony Brook University Hospital
Stony Brook, New York, United States
Recruiting
Mission Memorial Hospital
Asheville, North Carolina, United States
Recruiting
Aultman Hospital
Canton, Ohio, United States
Recruiting
The Christ Hospital
Cincinnati, Ohio, United States
Recruiting
Ascension St. John Jane Phillips Medical Center
Bartlesville, Oklahoma, United States
Recruiting
Saint Francis Hospital
Tulsa, Oklahoma, United States
Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Recruiting
Grand Strand Medical Center
Myrtle Beach, South Carolina, United States
Recruiting
Spartanburg Regional Health System
Spartanburg, South Carolina, United States
Recruiting
TriStar Centennial Medical Center
Nashville, Tennessee, United States
Recruiting
HCA Houston Healthcare Medical Center
Houston, Texas, United States
Recruiting
Bellin Health
Green Bay, Wisconsin, United States
Recruiting

Showing 22 of 22 sites. 22 of the 22 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07135895. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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