The Artix All-in-one Solution for Complete thrombEctomy With eNDovascular Approach
Inari Medical
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 be…
Interventions
- DeviceArtix Thrombectomy System
Treatment of lower extremity arterial occlusions using the Artix Thrombectomy System.
Locations (5)
- Yale UniversityNew Haven, Connecticut
- MedStar Washington Hospital CenterWashington D.C., District of Columbia
- Mission Memorial HospitalAsheville, North Carolina
- Ascension St. John Jane Phillips Medical CenterBartlesville, Oklahoma
- Grand Strand Medical CenterMyrtle Beach, South Carolina