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New treatment option for Acute Lower Limb Arterial Occlusion
Official title The ArtixASCEND Study
ClinicalTrials.gov ID: NCT07135895
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 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...
- Current participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this study
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Pensacola, Florida, United States
- Houma, Louisiana, United States
- Boston, Massachusetts, United States
- Midland, Michigan, United States
- Camden, New Jersey, United States
- Asheville, North Carolina, United States
- Canton, Ohio, United States
- Cincinnati, Ohio, United States
- Bartlesville, Oklahoma, United States
- Tulsa, Oklahoma, United States
- Pittsburgh, Pennsylvania, United States
- Myrtle Beach, South Carolina, United States
- Spartanburg, South Carolina, United States
- Nashville, Tennessee, United States
- Green Bay, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Washington D.C., District of Columbia, United States; Pensacola, Florida, United States; Houma, Louisiana, United States; Boston, Massachusetts, United States; Midland, Michigan, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.