Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625801
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
IVUS CHIP Diversity Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures Diversity Registry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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 IVUS CHIP Diversity Registry is a prospective observational multicenter single-arm registry A total of 1010 patients with complex coronary lesions will be enrolled in up to 2 years with at least 500 men and women All patients will be treated with IVUS-guided PCI
Detailed Description:
Objective is to describe in a United States population the clinical efficacy and safety of an IVUS-guided approach in patients who self-identify within a census-defined minority undergoing PCI of complex coronary lesions as well as clinical outcomes up to 2 years
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