Not a traditional drug phase: Artix Thrombectomy System for Acute Lower Limb Arterial Occlusion
This study is a post-market, prospective, multicenter, single-arm study to measure the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.
Official registry: https://clinicaltrials.gov/study/NCT07135895 · Inari Medical · enrollment listed as 250
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Artix Thrombectomy System. The registry lists allocation as na. This study is a post-market, prospective, multicenter, single-arm study to measure the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.
They plan to enroll about 250 people at 26 sites. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
The Artix All-in-one Solution for Complete thrombEctomy With eNDovascular Approach
Interventions: Artix Thrombectomy System
Primary outcome (registry wording): Primary Effectiveness Endpoint
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
Who the registry excludes
- 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
Public study contact (from the registry)
James Allen
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
26 listed- California Pacific Medical Center Van Ness/Sutter Health — San Francisco, California (recruiting)
- Yale University — New Haven, Connecticut (recruiting)
- MedStar Washington Hospital Center — Washington D.C., District of Columbia (recruiting)
- Ascension Sacred Heart Pensacola — Pensacola, Florida (recruiting)
- Terrebonne General Hospital/Cardiovascular Institute of the South — Houma, Louisiana (recruiting)
- University of Maryland Medical Center — Baltimore, Maryland (recruiting)
- Mass General Hospital — Boston, Massachusetts (recruiting)
- MyMichigan Health — Midland, Michigan (recruiting)
- Cooper University Hospital — Camden, New Jersey (recruiting)
- NYP-Brooklyn Methodist Hospital — Brooklyn, New York (recruiting)
- Mount Sinai Medical Center NY — New York, New York (recruiting)
- Vassar Brothers Medical Center/Nuvance Health — Poughkeepsie, New York (recruiting)
FAQ about this NCT record
Is NCT07135895 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07135895?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07135895?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary