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The ArtixASCEND Study

Recruiting

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

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

Sponsor: Inari Medical · Participants: 250 · Started: Jan 7, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07135895

Locations in the U.S.

CaliforniaCalifornia Pacific Medical Center Van Ness/Sutter Health, San Francisco
ConnecticutYale University, New Haven
District of ColumbiaMedStar Washington Hospital Center, Washington D.C.
FloridaAscension Sacred Heart Pensacola, Pensacola
LouisianaTerrebonne General Hospital/Cardiovascular Institute of the South, Houma
MassachusettsMass General Hospital, Boston
MichiganMyMichigan Health, Midland
New JerseyCooper University Hospital, Camden
New YorkNYP-Brooklyn Methodist Hospital, Brooklyn
Vassar Brothers Medical Center/Nuvance Health, Poughkeepsie
Stony Brook University Hospital, Stony Brook
North CarolinaMission Memorial Hospital, Asheville
OhioAultman Hospital, Canton
The Christ Hospital, Cincinnati
OklahomaAscension St. John Jane Phillips Medical Center, Bartlesville
Saint Francis Hospital, Tulsa
PennsylvaniaAllegheny General Hospital, Pittsburgh
South CarolinaGrand Strand Medical Center, Myrtle Beach
Spartanburg Regional Health System, Spartanburg
TennesseeTriStar Centennial Medical Center, Nashville
TexasHCA Houston Healthcare Medical Center, Houston
WisconsinBellin Health, Green Bay

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.