NCT07135895

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jan 2026Oct 2029

First Submitted

Initial submission to the registry

August 13, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

January 7, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

August 13, 2025

Last Update Submit

March 2, 2026

Conditions

Acute Lower Limb Arterial Occlusion

Keywords

Acute Limb IschemiaLower limb arterial occlusionArtix Thrombectomy System

Outcome Measures

Primary Outcomes (2)

  • Primary Effectiveness Endpoint

    Revascularization rate post-index procedure of target treatment area determined by an independent core lab.

    Immediately Following Index Procedure

  • Primary Safety Endpoint

    Periprocedural (within 48 hours) Artix Thrombectomy System-related major bleeding rate adjudicated as causal to the study device as determined by an independent Medical Monitor.

    48 Hours

Secondary Outcomes (4)

  • Distal embolization SAEs

    Intra-procedure

  • All-cause mortality

    1-month follow-up visit

  • Limb salvage

    1-month follow-up visit

  • Amputation-free survival

    1-month follow-up visit

Study Arms (1)

Artix Thrombectomy System

EXPERIMENTAL

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

Device: Artix Thrombectomy System

Interventions

Artix Thrombectomy SystemDEVICE

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

Artix Thrombectomy System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

MedStar Washington Hospital Center

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

RECRUITING

Mission Memorial Hospital

Asheville, North Carolina, 28801, United States

RECRUITING

Ascension St. John Jane Phillips Medical Center

Bartlesville, Oklahoma, 74006, United States

RECRUITING

Grand Strand Medical Center

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Study Officials

  • Ashleigh Willson

    Inari Medical

    STUDY DIRECTOR

  • Anahita Dua, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Shang Loh, MD

    Penn Presbyterian Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James Allen

CONTACT

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

Chris Ottaviano

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2025

First Posted

August 22, 2025

Study Start

January 7, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(5)