Recruiting

Artix Thrombectomy

Sponsor:

Inari Medical

Code:

NCT07135895

Conditions

Acute Lower Limb Arterial Occlusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Artix Thrombectomy System

Study Details

Brief 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.

Conditions

Acute Lower Limb Arterial Occlusion

Study ID

NCT07135895

Start date

Jan 7, 2026

Status verified date

Aug, 2026

Completion date

Oct 1, 2029

Anticipated

Primary completion date

Mar 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Artix Thrombectomy System

Non-surgical removal of lower extremity arterial emboli and thrombi using the Artix Thrombectomy System.

Interventions

Artix Thrombectomy System

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

Primary outcome measure

  • Primary Effectiveness Endpoint [ Time Frame: Immediately Following Index Procedure ]
  • Primary Safety Endpoint [ Time Frame: 48 Hours ]

Central Contacts and Locations

Central contacts

James Allen

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

Chris Ottaviano

609-634-4571chris.ottaviano@stryker.com

Locations

California Pacific Medical Center Van Ness/Sutter Health

Recruiting

San Francisco, California, United States, 94109

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Ascension Sacred Heart Pensacola

Recruiting

Pensacola, Florida, United States, 32504

Terrebonne General Hospital/Cardiovascular Institute of the South

Recruiting

Houma, Louisiana, United States, 70360

Mass General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

MyMichigan Health

Recruiting

Midland, Michigan, United States, 48670

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

NYP-Brooklyn Methodist Hospital

Recruiting

Brooklyn, New York, United States, 11215

Vassar Brothers Medical Center/Nuvance Health

Recruiting

Poughkeepsie, New York, United States, 12601

Mission Memorial Hospital

Recruiting

Asheville, North Carolina, United States, 28801

Aultman Hospital

Recruiting

Canton, Ohio, United States, 44710

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Ascension St. John Jane Phillips Medical Center

Recruiting

Bartlesville, Oklahoma, United States, 74006

Saint Francis Hospital

Recruiting

Tulsa, Oklahoma, United States, 74136

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Grand Strand Medical Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Spartanburg Regional Health System

Recruiting

Spartanburg, South Carolina, United States, 29303

TriStar Centennial Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Bellin Health

Recruiting

Green Bay, Wisconsin, United States, 54301

More Information

Sponsor

Inari Medical

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • Acute Limb Ischemia
  • Lower limb arterial occlusion
  • Artix Thrombectomy System

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Inari Medical on 2026-08-07.