Ignite Creation Date:
2024-05-05 @ 10:05 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01024179
Status:
UNKNOWN
Last Update Posted:
2009-12-07
First Post:
2009-12-01
Brief Title:
Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns
Sponsor:
Harbin Medical University
Organization:
Harbin Medical University
Study Overview
Official Title:
Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns After Sirolimus-eluting Stent Implantation Assessment by Optical Coherence Tomography
Status:
UNKNOWN
Status Verified Date:
2009-12
Last Known Status:
RECRUITING
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:
Vulnerable plaque characterized by thin fibrous cap and large lipid core is an independent risk factor for most of acute cardiac event Current clinical data showed that thin-cap fibroatheroma was more frequently observed in patients with ACS than SAP Further OCT study indicated that patients with ACS had significantly higher incidence of incomplete neointimal coverage and malapposition after DES implantation than those with SAP These findings imply that initial native lesion characteristics may be related to different vessel response neointimal coverage and malapposition after stenting However there is little data on the relationship between plaque characteristics and vascular response to DES after stent implantation evaluated by OCT
Therefore this study was designed to investigate the relationship between initial plaque characteristics and stent surface coverage or late malapposition after SES implantation The investigators will use high resolution OCT to assess the initial culprit plaque morphology and subsequent vascular response after SES stenting at the time points of post-stenting 6 months and 12 months IVUS will also be performed to evaluate the tissue protrusion malapposition vessel remodeling at the same time points
Therefore this study was designed to investigate the relationship between initial plaque characteristics and stent surface coverage or late malapposition after SES implantation The investigators will use high resolution OCT to assess the initial culprit plaque morphology and subsequent vascular response after SES stenting at the time points of post-stenting 6 months and 12 months IVUS will also be performed to evaluate the tissue protrusion malapposition vessel remodeling at the same time points
Detailed Description:
None
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