Clinical Trial

The Ladera Suture-Mediated Large Bore Closure Pivotal Study

Study acronym: FASTEN II
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07541235
Lead Sponsor Ladera Medical
Conditions Vascular Closure Device
Enrollment 214 participants
Start Date 2026-08
Primary Completion 2027-08 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-04-21