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Clinical trial

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

NCT07541235 is registered in ClinicalTrials.gov with Ladera Medical as lead sponsor.

NCT NCT07541235
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Registry record

As filed in ClinicalTrials.gov.

Title
A Prospective, Multi-Center, Single-Arm Pivotal Study to Evaluate the Safety and Efficacy of the Ladera Medical Suture-Mediated Large Bore Closure System When Used to Achieve Hemostasis of Common Femoral Arteriotomies in Patients Undergoing Percutaneous Catheter-Based Interventional Procedures (FASTEN II)
Lead sponsor
Ladera Medical
Phase
Not applicable
Overall status
Not yet recruiting
Start date
August 31, 2026
Completion date
October 31, 2027
Enrollment
214 (estimated)
Sites
1

Conditions

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

vascular closure device