Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device

Femoral Arteriotomy Closure Clinical Trial

Official title: Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety and performance of the MANTA Vascular Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular procedures utilizing large bore sheaths for purposes of supporting a CE Mark (Conformite Europeenne--"European Conformity") and other regulatory submissions. The study will assess whether the MANTA VCD is safe and performs as intended for large-bore vascular closure after interventional procedures.

Clinical Trial Description

The purpose of this study is to evaluate the safety and performance of MANTA in achieving hemostasis in femoral arterial access sites in patients undergoing percutaneous transcatheter interventional procedures using a 10-18F procedure sheath (such as Transcather Aortic Valve Replacement (TAVR), Balloon Aortic Valvuloplasty (BAV) and Endovascular Aneurysm Repair (EVAR)) for purposes of obtaining a CE Mark in the European Union.

The study will evaluate hemostasis success, time to hemostasis and ambulation, treatment success, and the rate of access-site-related complications in comparison to published literature on other hemostasis techniques for closing these large bore punctures (primarily, surgical closure and suture-mediated percutaneous closure. ;

Related Conditions & MeSH terms

• Femoral Arteriotomy Closure

• NCT number: NCT02521948
• Study type: Interventional
• Source: Essential Medical, Inc.
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Completion date: May 2016