Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-25 @ 2:17 PM
Study NCT ID:
NCT05142566
Status:
TERMINATED
Last Update Posted:
2023-07-27
First Post:
2021-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MANTA Ultrasound Closure Study
Sponsor:
Essential Medical, Inc.
Organization:
Study Overview
Official Title:
Prospective Multicenter MANTA™ Vascular Closure Device Ultrasound Guided Closure Study
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Ineffective enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MANTA ULTRA
Brief Summary:
Demonstrate the safety of MANTA Vascular Closure Device (VCD) ultrasound (U/S) guided closure in patients undergoing elective TAVR procedures with planned percutaneous femoral arterial access.
Detailed Description:
The MANTA Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures.
This study is being conducted to demonstrate the safety of U/S guided closure with MANTA VCD following TAVR procedures utilizing large bore sheaths.
This study is being conducted to demonstrate the safety of U/S guided closure with MANTA VCD following TAVR procedures utilizing large bore sheaths.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: