The Ladera Suture-Mediated Large Bore Closure Pivotal Study (NCT07541235) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Ladera Suture-Mediated Large Bore Closure Pivotal Study
Australia214 participantsStarted 2026-08
Plain-language summary
The study objective is to demonstrate the safety and efficacy of the investigational device to achieve hemostasis of common femoral artery access sites in participants undergoing percutaneous interventional catheterization procedures utilizing 10 to 24 Fr introducer sheaths.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant is ≥ 18 years old
✓. Participant 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, EVAR, TEVAR)
✓. Participant is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
✓. Participant is willing and able to complete follow-up requirements
✓. Participant 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
✕. Participants 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, and/or DUS
✕. Common femoral artery and iliac lumen diameter is \< 6 mm as confirmed with prior standard of care CT Imaging, angiography, and/or DUS
✕. Common femoral artery calcium at the arteriotomy site (i.e., target access site), which is visible with prior CT Imaging and/or DUS
✕. Marked tortuosity (at the Investigator's discretion) of the femoral or external iliac artery in the target leg based on prior CT Imaging, angiography, and/or DUS