This study is a post-market, prospective, multicenter, single-arm trial to evaluate the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.
Objective
- Evaluate the safety and effectiveness of the Artix Thrombectomy System in patients with lower extremity arterial occlusions
Design
Prospective, single-arm, multicenter trial
- Up to 250 patients at up to 50 US sites
Primary endpoints
- Effectiveness: Revascularization rate post-index procedure of target treatment area determined by an independent core lab
- Safety: Periprocedural device-related major bleeding rate adjudicated by an independent medical monitor
Key eligibility criteria
- Acute symptom duration ≤14 days
- Lower limb arterial occlusion below inguinal ligament
- Target lesion in native vessels
- Rutherford category I, IIa, or IIb
Other endpoints
- All-cause mortality
- Limb salvage
- Distal embolization SAEs
- Adjunctive therapy
- Blood loss
Duration of patient follow-up
- Patients are assessed at discharge, 1 month, 3 months, and 6 months
Indications for Use
The Artix Thin-Walled Sheath is indicated for (1) the non-surgical removal of emboli and thrombi from blood vessels, (2) injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel, (3) use as a conduit for endovascular devices, (4) use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The funnel provides temporary vascular occlusion during these and other angiographic procedures. The Artix Thin-Walled Sheath is intended for use in the peripheral vasculature. The Artix MT Thrombectomy Device is indicated for (1) the non-surgical removal of emboli and thrombi from a blood vessel, (2) injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Artix MT Thrombectomy Device is intended for use in the peripheral vasculature. The Artix AX Aspiration Catheter is indicated for (1) the non-surgical removal of emboli and thrombi from blood vessels, (2) injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Artix AX Aspiration Catheter is intended for use in the peripheral vasculature. The FlowSaver Blood Return System is used with Inari Medical catheters and sheaths for autologous blood transfusion.
Review complete Instructions for Use, Indications for Use, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.
Caution
Federal (USA) law restricts this device to sale by or on the order of a physician.
PRO-4515-USA-EN-v1