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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Artix Thrombectomy System 		Non-surgical removal of lower extremity arterial emboli and thrombi using the Artix Thrombectomy System.
  • Device: Artix Thrombectomy System
    Treatment of lower extremity arterial occlusions using the Artix Thrombectomy System.

Recruiting Locations

Yale University
New Haven, Connecticut 06510
Contact:
Edouard Aboian, MD

MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010
Contact:
Kyle Reynolds, MD

MyMichigan Health
Midland, Michigan 48670
Contact:
Jacob Frisbie, DO

Cooper University Hospital
Camden, New Jersey 08103
Contact:
Bruce Tjaden Jr, MD

Mission Memorial Hospital
Asheville, North Carolina 28801
Contact:
John Henretta, MD

The Christ Hospital
Cincinnati, Ohio 45219
Contact:
Christopher Paprzycki, MD

Ascension St. John Jane Phillips Medical Center
Bartlesville, Oklahoma 74006
Contact:
Anderson Mehrle, MD

Saint Francis Hospital
Tulsa, Oklahoma 74136
Contact:
Andres Andres Guerra, MD

Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Contact:
Satish Muluk, MD

Grand Strand Medical Center
Myrtle Beach, South Carolina 29572
Contact:
Christian Salinas, MD

Bellin Health
Green Bay, Wisconsin 54301
Contact:
Sumit Ringwala, MD

More Details

Status
Recruiting
Sponsor
Inari Medical

Study Contact

James Allen
651-279-8587
james.allen2@stryker.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.