Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06212193
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-12-20
Brief Title:
Innoventric Trillium Stent Graft Early Feasibility Study EFS
Sponsor:
Innoventric LTD
Organization:
Innoventric LTD
Study Overview
Official Title:
Early Feasibility Study EFS to Assess the Safety and Performance of the Innoventric Trillium Stent Graft in the Treatment of Severe or Greater Tricuspid Regurgitation TR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
None
Brief Summary:
Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium Stent Graft in the treatment of severe or greater tricuspid regurgitation TR
Detailed Description:
Prospective single arm multi-center Early Feasibility Study EFS to assess the safety and performance of the Innoventric Trillium Stent Graft in the treatment of severe or greater tricuspid regurgitation TR
Up to fifteen 15 patients at up to 10 investigational sites will be enrolled All enrolled study patients will be assessed at baseline during the procedure at discharge and after 1 month 3 months 6 months 1 year 2 years 3 years 4 years and 5 years following the index procedure
Up to fifteen 15 patients at up to 10 investigational sites will be enrolled All enrolled study patients will be assessed at baseline during the procedure at discharge and after 1 month 3 months 6 months 1 year 2 years 3 years 4 years and 5 years following the index procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None