Ignite Creation Date:
2024-05-06 @ 7:22 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02521948
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2015-08-07
Brief Title:
Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
Sponsor:
Essential Medical Inc
Organization:
Essential Medical Inc
Study Overview
Official Title:
Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None