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Clinical trial

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)

NCT06851481 is registered in ClinicalTrials.gov with Ladera Medical as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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)
Lead sponsor
Ladera Medical
Phase
Not applicable
Overall status
Completed
Start date
August 18, 2025
Completion date
May 15, 2026
Enrollment
55 (actual)
Sites
6

Conditions

As the registry lists them; a condition with its own page is linked.

femoral arteriotomy closure, vascular closure