NCT06851481

The Ladera Suture-Mediated Large Bore Closure Study

A Prospective, Multi-Center, Single-Arm Study to Evaluate the Safety and Performance of the Ladera Medical Suture-Mediated Closure System When Used to Achieve Hemostasis of Common Femoral Arteriotomies in Patients Undergoing Percutaneous Catheter-Based Interventional Procedures (the FASTEN Study)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Ladera Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Vascular Closure
• Femoral Arteriotomy Closure

Interventions

Type	Name	Description
DEVICE	Ladera LBC System	Use of the Ladera LBC System to close the femoral arteriotomy

Timeline

• Start date: 2025-08-18
• Primary completion: 2025-12-30
• Completion: 2025-12-31
• First posted: 2025-02-28
• Last updated: 2025-12-15

Locations

6 sites across 3 countries: Australia, Belgium, Netherlands

Regulatory

• FDA-regulated device study