Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507865
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Post Market Registry for GORE TAG Thoracic Branch Endoprosthesis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Characterization of Mid-term Post Market Clinical Follow Up of GORE TAG Thoracic Branch Endoprosthesis Facilitated Aortic Arch and Descending Aorta Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE TAG Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular disease This registry aims to answer questions related to the efficacy and safety of GORE TAG Thoracic Branch Endoprosthesis
Detailed Description:
The purpose of the GORE TAG Thoracic Branch Endoprosthesis Registry is to collect real-world data for this device Due to the nature of the registry patient selection diagnostic imaging and treatment interventions will be determined by physicians based on standard clinical practice Therefore the Sponsor will not be outlining requirements that would influence healthcare decisions
Participants will be asked to return for regular scheduled visits as requested by their surgeon Patients will report any issues they may have regarding the device or surgery to their surgeondoctor
Participants will be asked to return for regular scheduled visits as requested by their surgeon Patients will report any issues they may have regarding the device or surgery to their surgeondoctor
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