Ignite Creation Date:
2024-05-06 @ 3:50 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02384837
Status:
COMPLETED
Last Update Posted:
2016-12-06
First Post:
2014-12-25
Brief Title:
Effect of TCFA on Neointimal Coverage After PCI at 9 Months Follow-up
Sponsor:
General Hospital of Chinese Armed Police Forces
Organization:
General Hospital of Chinese Armed Police Forces
Study Overview
Official Title:
Effect of TCFA on Neointimal Coverage After EXCEL Biodegradable Polymer-coated Sirolimus-eluting Stents Implantation at 9 Months Follow-up Evaluated by Optical Coherence Tomography and Fractional Flow Reserve
Status:
COMPLETED
Status Verified Date:
2015-01
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:
None
Brief Summary:
Although drug-eluting stents have reduced rates of restenosis and late lumen loss compared with bare metal stents late stent thrombosis LST a life-threatening complication of this technology has emerged as a major concern Researches indicated incomplete neointimal coverage of stent struts as the most important morphometric predictor of LST Pathological research showed stenting disruption of adjacent vulnerable plaques can precipitate LST Meanwhile thin-cap fibroatheromas TCFA as the most important predictor of Major Adverse Cardiovascular Therefore there is a hypothesis that TCFA may impair intimal healing which are prone to LST in vivo
Optical coherence tomography OCTis a high-resolution 10 µm catheter-based imaging modality capable of investigating detailed coronary plaque morphology in vivoThis study aimed to observe that TCFA will arise what of the effect on intimal healing of stent struts on the lesions which fractional flow reserve FFR075 after EXCEL biodegradable polymer-coated sirolimus-eluting stent was implanted at 9 months follow up evaluated by OCT and FFR
Optical coherence tomography OCTis a high-resolution 10 µm catheter-based imaging modality capable of investigating detailed coronary plaque morphology in vivoThis study aimed to observe that TCFA will arise what of the effect on intimal healing of stent struts on the lesions which fractional flow reserve FFR075 after EXCEL biodegradable polymer-coated sirolimus-eluting stent was implanted at 9 months follow up evaluated by OCT and FFR
Detailed Description:
The primary end point is to Neointimal coverage after 9 months of the stent implantation
Quality assurance plan that addresses data validation and registry procedures including any plans for site monitoring and auditing
Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry
Source data verification to assess the accuracy completeness or representativeness of registry data by comparing the data to external data sources eg medical records paper or electronic case report forms or interactive voice response systems
Data dictionary that contains detailed descriptions of each variable used by the registry including the source of the variable coding information if used and normal ranges if relevant
Standard Operating Procedures to address registry operations and analysis activities such as patient recruitment data collection data management data analysis reporting for adverse events and change management
Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect
Quality assurance plan that addresses data validation and registry procedures including any plans for site monitoring and auditing
Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry
Source data verification to assess the accuracy completeness or representativeness of registry data by comparing the data to external data sources eg medical records paper or electronic case report forms or interactive voice response systems
Data dictionary that contains detailed descriptions of each variable used by the registry including the source of the variable coding information if used and normal ranges if relevant
Standard Operating Procedures to address registry operations and analysis activities such as patient recruitment data collection data management data analysis reporting for adverse events and change management
Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect
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