Artix Thrombectomy System for acute lower limb arterial occlusion
The Artix All-in-one Solution for Complete thrombEctomy With eNDovascular Approach
NA · Inari Medical · NCT07135895
This study tests the Artix Thrombectomy System to remove clots and restore blood flow in adults with acute lower limb arterial occlusions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Inari Medical (industry) |
| Locations | 11 sites (New Haven, Connecticut and 10 other locations) |
| Trial ID | NCT07135895 on ClinicalTrials.gov |
What this trial studies
This post-market, prospective, multicenter, single-arm study enrolls adults with acute lower extremity arterial occlusions treated with the Artix Thrombectomy System. Participants must have symptom duration ≤14 days, a target native vessel 3–8 mm in diameter below the inguinal ligament, and Rutherford category I–IIb ischemia. The Artix device is used as the primary endovascular method for clot removal, with clinicians following local standards for adjunctive treatments and follow-up. Outcomes focus on device safety and technical and clinical effectiveness, including revascularization and limb-related clinical endpoints.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18 years) with acute (≤14 days) native lower limb arterial occlusion below the inguinal ligament, target vessel diameter 3–8 mm, and Rutherford category I–IIb who can provide informed consent.
Not a fit: Patients unlikely to benefit include those with non-thrombotic occlusions (e.g., dissection or vasculitis), prior treatment of the index event, major unhealed amputations in the target limb, limited life expectancy (<6 months), pregnancy, or known sensitivity to radiographic contrast.
Why it matters
Potential benefit: If successful, the device could enable faster clot removal and improved limb salvage while reducing the need for open surgery.
How similar studies have performed: Other mechanical thrombectomy devices have shown benefit in restoring flow and reducing amputation risk in acute limb ischemia, and device-specific post-market data for Artix are now being collected.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Haven, Connecticut and 10 other locations
- Yale University — New Haven, Connecticut, United States (RECRUITING)
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (RECRUITING)
- MyMichigan Health — Midland, Michigan, United States (RECRUITING)
- Cooper University Hospital — Camden, New Jersey, United States (RECRUITING)
- Mission Memorial Hospital — Asheville, North Carolina, United States (RECRUITING)
- The Christ Hospital — Cincinnati, Ohio, United States (RECRUITING)
- Ascension St. John Jane Phillips Medical Center — Bartlesville, Oklahoma, United States (RECRUITING)
- Saint Francis Hospital — Tulsa, Oklahoma, United States (RECRUITING)
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (RECRUITING)
- Grand Strand Medical Center — Myrtle Beach, South Carolina, United States (RECRUITING)
- Bellin Health — Green Bay, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Anahita Dua, MD — Massachusetts General Hospital
- Study coordinator: James Allen
- Email: james.allen2@stryker.com
- Phone: 651-279-8587
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Lower Limb Arterial Occlusion, Acute Limb Ischemia, Lower limb arterial occlusion, Artix Thrombectomy System