The Ladera Suture-Mediated Large Bore Closure Pivotal Study
ConditionVascular Closure Device
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLadera Medical
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Ladera LBC System
DeviceUse of the Ladera LBC System to close the femoral arteriotomy
Treatment groups
214 Participants
are divided into 1 treatment groupGroup A: The Ladera LBC System will be used in all participants enrolled in the studyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Safety Endpoint
Freedom from Clinical Events Committee (CEC) adjudicated major complications of the target limb access site within 30 days post-procedure
Time frame
30 days2
Primary Performance Endpoint: Time to Hemostasis
The mean Time to Hemostasis (TTH) in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device.
Time frame
Post-procedure, usually within 3 hoursSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: