Ladera Medical
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.
Vascular Closure
Femoral Arteriotomy Closure
Ladera LBC System
Not Applicable
The Ladera Medical suture mediated large bore closure (LBC) system is a vascular closure device intended for use in catheterization laboratories following percutaneous interventional catheterization procedures that use the retrograde common femoral artery access route for large bore interventional devices. The function of Ladera LBC System is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure. The study is being conducted to demonstrate the safety and performance of the LBC System in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous interventional catheterization procedures using a large-bore procedure sheath.
Study Type : | Interventional |
Estimated Enrollment : | 30 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | Evaluation of the Safety and Performance of the Ladera Medical Suture-Mediated Large Bore Closure (LBC) System |
Actual Study Start Date : | July 2024 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | February 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Ladera LBC System The Ladera LBC System will be used in all participants enrolled in the study |
Device: Ladera LBC System |
Ages Eligible for Study: | 21 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.