Ladera Suture-Mediated Large Bore Closure Pivotal Study
ClinicalTrials.gov Studies
Summary
The NIH ClinicalTrials.gov registry has registered a new pivotal clinical study for the Ladera Suture-Mediated Large Bore Closure (LBC) System. The study aims to demonstrate the safety and efficacy of the investigational vascular closure device for achieving hemostasis of common femoral artery access sites in patients undergoing percutaneous interventional catheterization procedures using 10 to 24 French introducer sheaths.
“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.”
What changed
The NIH ClinicalTrials.gov has added registration for a new pivotal clinical study evaluating the Ladera LBC System as an investigational vascular closure device. The study is registered as NCT07541235 and will enroll participants undergoing percutaneous interventional catheterization procedures utilizing 10 to 24 French introducer sheaths.
Manufacturers of vascular closure devices and healthcare providers conducting percutaneous interventional procedures should be aware of this emerging competitor in the large-bore closure space. The study's focus on 10-24 Fr introducer sheaths indicates targeting complex interventional procedures such as transcatheter aortic valve replacements (TAVR) and endovascular aneurysm repairs (EVAR).
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
The Ladera Suture-Mediated Large Bore Closure Pivotal Study
N/A NCT07541235 Kind: NA Apr 21, 2026
Abstract
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.
Conditions: Vascular Closure Device
Interventions: Ladera LBC System
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