The Ladera Suture-Mediated Large Bore Closure Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLadera Medical
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
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
55 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: Major Arterial Access Site Closure-related Complications
Freedom from Clinical Events Committee (CEC) adjudicated major complications of the target limb access site within 30 days post-procedure
Time frame
30 days post-procedure2
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
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov