This study evaluates the safety and performance of the Ladera Medical suture-mediated large bore closure (LBC) system in gaining post procedure hemostasis in subjects undergoing interventional catheterization procedures using a large-bore procedure sheath.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient is ≥ 18 years old
✓. Patient is scheduled for elective or planned (i.e., not emergent or urgent) percutaneous interventional catheterization procedures involving access through the common femoral artery using 10 to 24 Fr introducer sheaths (i.e., BAV, TAVR/TAVI, PEVAR, TEVAR)
✓. Patient is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
✓. Patient is willing and able to complete follow-up requirements
✓. Patient has the mental capacity to consent for themselves (i.e., does not require the use of a Legally Authorized Representative), and signs a written Informed Consent Form (ICF) prior participating in the study
Exclusion criteria
✕. Prior intra-aortic balloon pump at access site within 30 days of baseline evaluation
✕. Patients with severe inflow disease (iliac artery diameter stenosis \> 50%) and/or severe peripheral arterial disease (Rutherford Classification 5 or 6), as confirmed with prior standard of care Computed Tomography (CT) Imaging
✕. Common femoral artery and iliac lumen diameter is \< 6 mm as confirmed with prior standard of care CT Imaging
✕. Common femoral artery calcium at the arteriotomy site (i.e., target access site), which is visible with prior CT Imaging
✕. Marked tortuosity (at the investigator's discretion) of the femoral or external iliac artery in the target leg based on prior CT Imaging
What they're measuring
1
Primary Safety Endpoint: Major Arterial Access Site Closure-related Complications