Ignite Creation Date:
2024-05-06 @ 8:56 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02868203
Status:
UNKNOWN
Last Update Posted:
2016-08-16
First Post:
2016-08-11
Brief Title:
OCT Based Edge and In-stent Vascular Response After Cordimax Stent in patIents With NSTE-ACS
Sponsor:
Xijing Hospital
Organization:
Xijing Hospital
Study Overview
Official Title:
Optical Coherence tOmography Based Edge and In-stent Vascular Response After a Novel bioDegradable Polymer sIrolimus-eLuting Stent in patIents With Non-ST Elevation acuTe Coronary sYndrome NSTE ACS
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
NOT_YET_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:
This study evaluates the completeness of strut coverage and vessel wall response at different time points 3-6-12 Months following CordimaxTM stent implantation in patients with non-ST elevation acute coronary syndrome
Detailed Description:
Major concerns were addressed to the delayed healing process of drug-eluting stents To date no studies have detailed the in-vivo completeness of CordimaxTM stent coverage at different time points The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response neointima disomogeneity acquired late incomplete strut apposition at different time points following CordimaxTM stent implantation in patients with non-ST elevation acute coronary syndrome Optical Coherence Tomography OCT that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at different time points 3-6-12 Months
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