Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270537
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-01-09
Brief Title:
Post-market Clinical Trial of the Dominus Stent-Graft
Sponsor:
Braile Biomedica Ind Com e Repr Ltda
Organization:
Braile Biomedica Ind Com e Repr Ltda
Study Overview
Official Title:
Multicenter Study Collecting Post-market Clinical Data on the Dominus Stent-Graft for Treating Thoracic Aortic Diseases
Status:
RECRUITING
Status Verified Date:
2024-08
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:
DominusPMCF
Brief Summary:
Real-world clinical trial evidence post-market evaluating the safety and efficacy of the Dominus StentGraft Endoprosthesis in treating thoracic aortic diseases following the Instructions for Use
Detailed Description:
The multicenter study aims to collect post-market clinical data on the Dominus Stent-Graft in the treatment of thoracic aortic diseases With the goal of assessing safety and efficacy the prospective follow-up study will include 100 patients undergoing Endovascular Treatment of Thoracic Aortic Diseases following the products Instructions for Use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None