Acute Lower Limb Arterial Occlusion
Conditions
Keywords
Acute Limb Ischemia, Lower limb arterial occlusion, Artix Thrombectomy System
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.
Interventions
DEVICEArtix Thrombectomy System
Treatment of lower extremity arterial occlusions using the Artix Thrombectomy System.
Sponsors
Inari Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint | Immediately Following Index Procedure | Revascularization rate post-index procedure of target treatment area determined by an independent core lab. |
| Primary Safety Endpoint | 48 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distal embolization SAEs | Intra-procedure | — |
| All-cause mortality | 1-month follow-up visit | — |
| Limb salvage | 1-month follow-up visit | Freedom from major amputation of the index limb |
| Amputation-free survival | 1-month follow-up visit | Freedom from major amputation and all-cause mortality |
Countries
United States
Contacts
CONTACTJames Allen
CONTACTChris Ottaviano
STUDY_DIRECTORScott T Lewis
Inari Medical
PRINCIPAL_INVESTIGATORAnahita Dua, MD
Massachusetts General Hospital
PRINCIPAL_INVESTIGATORShang Loh, MD
Penn Presbyterian Medical Center
Outcome results
None listed