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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. In opinion of the Investigator, significant scarring of the target access site which would preclude use of the device in accordance with the IFU
. Prior target artery closure with any closure device \< 90 days, or closure with manual compression ≤ 30 days prior to index procedure
. Prior atherectomy, vascular surgery, vascular graft, or stent in region of access site