Ignite Creation Date:
2024-05-06 @ 9:06 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02908880
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2016-09-09
Brief Title:
MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study
Sponsor:
Essential Medical Inc
Organization:
Essential Medical Inc
Study Overview
Official Title:
Pivotal Clinical Study to EvaluAte the SaFety and Effectiveness of MANTA Vascular Closure Device
Status:
COMPLETED
Status Verified Date:
2019-09
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:
SAFE_MANTA
Brief Summary:
Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure The MANTA device is expected to seal the femoral access puncture in less than 1 minute This may result in less blood loss and a shorter time to walking compared to alternative closure means Use of the MANTA device in this study is experimental All other parts of the procedure involve standard medical care
Detailed Description:
The MANTA device is a VCD intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore 10-18F ID interventional devices The function of MANTA is to percutaneously close the puncture in the artery wall arteriotomy through which the catheters were inserted for the procedure
The study is being conducted to demonstrate the safety and effectiveness of MANTA in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath
The study is being conducted to demonstrate the safety and effectiveness of MANTA in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath
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