Clinical Study of the Medeon Biodesign XPro™

Percutaneous Closure of Arteriotomy in Common Femoral Artery Clinical Trial

Official title: Prospective, Multi-Center, Single Arm Study of the Medeon Biodesign XPro™ Suture-Mediated Vascular Closure Device System

Status Completed

Clinical Trial Summary

To access the safety and performance of the XPro System to facilitate hemostasis in patients undergoing percutaneous endovascular procedures utilizing 8-18 Fr introducer sheath via the common femoral.

Clinical Trial Description

This is a prospective multi-center, single arm study to assess the safety and performance of the XPro System compared to a historical control developed from published studies of two marketed competitive devices, Perclose ProGlide® and Prostar® XL (both from Abbott Vascular, Inc., Redwood City, CA, USA). The goal of the study is to show that XPro System is non-inferior to the competitors in efficacy and safety. Patients scheduled for percutaneous BAV, TAVR/TAVI, EVAR, or TEVAR procedures using an 8-18 Fr introducer sheath will be screened for study eligibility. Patients will be followed for 30 days post procedure. ;

Related Conditions & MeSH terms

• Percutaneous Closure of Arteriotomy in Common Femoral Artery

• NCT number: NCT03171155
• Study type: Interventional
• Source: Medeon Biodesign, Inc.
• Status: Completed
• Phase: N/A
• Start date: May 25, 2017
• Completion date: September 12, 2019