Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 12:50 AM
Study NCT ID:
NCT00824434
Status:
COMPLETED
Last Update Posted:
2012-08-30
First Post:
2009-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Prospective, Multi-center Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™)
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
A Prospective, Multi-center Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™)
Status:
COMPLETED
Status Verified Date:
2012-08
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:
PLATINUM QCA
Brief Summary:
Compile acute (30-day) clinical outcomes data and 9-month angiographic and intravascular ultrasound (IVUS) data for the PROMUS Element™ Everolimus- Eluting Coronary Stent System in the treatment of patients with a single de novo atherosclerotic lesion
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: