Ignite Creation Date:
2024-05-06 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05089864
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2021-10-11
Brief Title:
STAR and Deferred Stenting Study
Sponsor:
Saint Lukes Health System
Organization:
Saint Lukes Health System
Study Overview
Official Title:
Outcomes and Safety in Patients Treated With STAR and Deferred Stenting After Unsuccessful CTO PCI
Status:
RECRUITING
Status Verified Date:
2024-05
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:
STAR
Brief Summary:
STAR is a minimal-risk pragmatic clinical trial of patients admitted for a CTO-PCI procedure The overall objective of the STAR Study is to address the current gaps in knowledge regarding use of STAR during CTO-PCI as a prospective multi-center study of 150 participants with randomization of timing of staged PCI Five sites will be selected to participate in STAR from a national network of highly experienced CTO-PCI centers across the United States
Detailed Description:
To date there have been no studies that prospectively and systemically evaluated the efficacy and safety of STAR with deferred stenting and described the frequency of its use in the hybrid approach The aim of this study is to address these current gaps in knowledge including the frequency of use of STAR by experienced operators the safety of its use optimal timing of staged stenting and health status change associated with this procedure This prospective study will enroll 150 patients undergoing elective PCI of native CTO utilizing the STAR technique and will subsequently randomize patients in a 11 fashion to early 5-7 weeks and later 12-14 weeks timing of subsequent stenting
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