Back to search results

ArtixASCEND Study for Acute Lower Limb Arterial Occlusion

This study is testing the Artix Thrombectomy System to treat acute lower limb arterial occlusion (a sudden blockage in an artery in your leg). We are looking at how safe and effective this device is. You may be able to join if you are 18 or older, have had symptoms for 14 days or less, and have a specific type of blockage in your leg artery. The study will measure how well the treatment works right after the procedure and check for safety issues within 48 hours. The current recruitment status is unclear, but the study plans to enroll about 250 people.

Study design
This is a single-arm study, meaning all participants will receive the Artix Thrombectomy System. It plans to enroll about 250 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will check how well the treatment works immediately after the procedure and monitor for safety issues for 48 hours.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07135895

The ArtixASCEND Study

Recruiting
NAAges 18+InterventionalTreatment
Inari Medical
~250 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:Artix Thrombectomy System

At a glance

Recruiting sites
20 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Effectiveness Endpoint
Measured over Immediately Following Index Procedure
+1 more outcome measured

Conditions

Acute Lower Limb Arterial Occlusion

Explore related trials

Limb ischemia

Where it's being run

20 sites across 16 states
New York2
Ohio2
Oklahoma2
South Carolina2
California1
Connecticut1
District of Columbia1
Florida1

Study leadership

  • Scott T Lewis · STUDY_DIRECTOR · Inari Medical
  • Anahita Dua, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
  • Shang Loh, MD · PRINCIPAL_INVESTIGATOR · Penn Presbyterian Medical Center

Who to contact

James Allen
[email protected]
651-279-8587
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Primary Effectiveness EndpointImmediately Following Index Procedure

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

  • Primary Safety Endpoint48 Hours

    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.