Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-04 @ 9:28 PM
Study NCT ID:
NCT03330002
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2017-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MANTA Registry for Vascular Large-bore Closure
Sponsor:
Essential Medical, Inc.
Organization:
Study Overview
Official Title:
Post-Market Clinical Registry to Evaluate the Safety and Performance of MANTA Vascular Closure Device (VCD) Under Real World Conditions in the European Union (EU)
Status:
COMPLETED
Status Verified Date:
2021-04
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:
MARVEL
Brief Summary:
The aim of this observational post market study is to compile real world outcome data on the use of the Conformité Européenne (CE) marked MANTA Vascular Closure Device following percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?: