Phase
Condition
N/ATreatment
Artix Thrombectomy System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 authorizedrepresentative (LAR) per Institutional Review Board/Ethics Committee requirements
Exclusion
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 cannotbear weight
Non-thrombotic occlusion secondary to dissection, vasculitis, or target vesseltrauma
Treatment of the index event in the target vessel with any other endovascularthrombectomy/aspiration or open surgical method prior to Artix procedure
Part of a vulnerable population (e.g., currently pregnant, breastfeeding orincarcerated) per local definitions
Known sensitivity to radiographic contrast agents that, in the Investigator'sopinion, cannot be adequately pre-treated
Unable to tolerate antiplatelet therapy
Inability to anticoagulate the patient with heparin, enoxaparin or other parenteralantithrombin, or known to have uncorrected bleeding disorders (e.g.,gastro-intestinal ulcer, menorrhagia, liver failure, heparin-inducedthrombocytopenia (HIT))
Any condition for which, in the opinion of the Investigator, participation would notbe in the best interest of the subject (e.g., contraindication to use of Artix perlocal approved labeling, compromise the well-being or that could prevent, limit, orconfound the protocol-specified assessments)
Current participation in another drug or device study that, in the investigator'sopinion, would interfere with participation in this study
Study Design
Connect with a study center
California Pacific Medical Center Van Ness/Sutter Health
San Francisco, California 94109
United StatesActive - Recruiting
Yale University
New Haven, Connecticut 06510
United StatesActive - Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010
United StatesActive - Recruiting
Ascension Sacred Heart Pensacola
Pensacola, Florida 32504
United StatesActive - Recruiting
Terrebonne General Hospital/Cardiovascular Institute of the South
Houma, Louisiana 70360
United StatesActive - Recruiting
Mass General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
MyMichigan Health
Midland, Michigan 48670
United StatesActive - Recruiting
Cooper University Hospital
Camden, New Jersey 08103
United StatesActive - Recruiting
NYP-Brooklyn Methodist Hospital
Brooklyn, New York 11215
United StatesActive - Recruiting
Vassar Brothers Medical Center/Nuvance Health
Poughkeepsie, New York 12601
United StatesActive - Recruiting
Stony Brook University Hospital
Stony Brook, New York 11794
United StatesActive - Recruiting
Mission Memorial Hospital
Asheville, North Carolina 28801
United StatesActive - Recruiting
Aultman Hospital
Canton, Ohio 44710
United StatesActive - Recruiting
The Christ Hospital
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Ascension St. John Jane Phillips Medical Center
Bartlesville, Oklahoma 74006
United StatesActive - Recruiting
Saint Francis Hospital
Tulsa, Oklahoma 74136
United StatesActive - Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesActive - Recruiting
Grand Strand Medical Center
Myrtle Beach, South Carolina 29572
United StatesActive - Recruiting
Spartanburg Regional Health System
Spartanburg, South Carolina 29303
United StatesActive - Recruiting
TriStar Centennial Medical Center
Nashville, Tennessee 37203
United StatesActive - Recruiting
HCA Houston Healthcare Medical Center
Houston, Texas 77004
United StatesActive - Recruiting
Bellin Health
Green Bay, Wisconsin 54301
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.