Actively Recruiting
The ArtixASCEND Study
Led by Inari Medical · Updated on 2026-05-11
250
Participants Needed
11
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The ArtixASCEND Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 18 years
- Acute symptom duration 64 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
MyMichigan Health
Midland, Michigan, United States, 48670
Actively Recruiting
4
Cooper University Hospital
Camden, New Jersey, United States, 08103
Actively Recruiting
5
Mission Memorial Hospital
Asheville, North Carolina, United States, 28801
Actively Recruiting
6
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
7
Ascension St. John Jane Phillips Medical Center
Bartlesville, Oklahoma, United States, 74006
Actively Recruiting
8
Saint Francis Hospital
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
9
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
10
Grand Strand Medical Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
11
Bellin Health
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
Research Team
J
James Allen
CONTACT
C
Chris Ottaviano
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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