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Clinical Trials in the USA / NCT07135895
Recruiting Not applicable

The ArtixASCEND Study

NCT07135895 · tracked via the Priya Life Science USA tracker
Sponsor
Inari Medical
Phase
Not applicable
Started
2026-01-07
Last updated
2026-08-07

Condition(s) studied

Acute Lower Limb Arterial Occlusion

Investigational drug(s) / intervention(s)

Artix Thrombectomy System

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (20)

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

More Inari Medical trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07135895 on ClinicalTrials.gov ↗ ← All trials in the USA