Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05755711
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-02-21
Brief Title:
Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
Sponsor:
Shockwave Medical Inc
Organization:
Shockwave Medical Inc
Study Overview
Official Title:
Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
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:
EMPOWER CAD
Brief Summary:
Post-market prospective multi-center single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease
Detailed Description:
Subject population up to 400 female subjects referred for percutaneous coronary intervention PCI with coronary IVL and stenting per standard of care at up to 50 global sites in the US UK and Europe Subjects will have clinical follow-up prior to discharge from the index intervention and at 30 days 1 2 and 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None