Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04665466
Status:
COMPLETED
Last Update Posted:
2021-04-02
First Post:
2020-12-06
Brief Title:
Implication of Coronary Artery Disease Burden and Pattern in Ischemia-causing Vessels With PCI
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
Combined AngiograpHy-derived Fractional Flow Reserve and Pullback Pressure Gradient Assessment to Better Discriminate Coronary ARTery Disease PAtients Benefiting From PercuTaneous Coronary InTERventioN
Status:
COMPLETED
Status Verified Date:
2021-03
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:
CHART-PATTERN
Brief Summary:
Ischemia-guided revascularization is the cornerstone of contemporary management of coronary artery disease CAD Coronary physiological assessment is advocated in the catheter laboratory to guide percutaneous coronary intervention PCI and it is widely accepted that an FFR 080 is a good indicator for vessels to benefit from revascularization Nevertheless a significant proportion of PCI patients continue to experience adverse events related to both stented segment andor residual or diffuse disease Our group recently demonstrated the feasibility of pullback pressure gradient PPG derived from virtual Quantitative Flow Ratio QFR pullback curve which is an index of atherosclerosis functional pattern and can be used to epitomize the pathophysiological pattern of CAD as focal or diffuse
In this regard the current study will investigate the incremental value of PPG added to QFR haemodynamic assessment in ischemia-causing vessels received PCI in predicting adverse outcomes
In this regard the current study will investigate the incremental value of PPG added to QFR haemodynamic assessment in ischemia-causing vessels received PCI in predicting adverse outcomes
Detailed Description:
Ischemia-guided revascularization is the cornerstone of contemporary management of coronary artery disease CAD Coronary physiological assessment is advocated in the catheter laboratory to guide percutaneous coronary intervention PCI and it is widely accepted that an FFR 080 is a good indicator for vessels to benefit from revascularization Nevertheless a significant proportion of PCI patients continue to experience adverse events related to both stented segment andor residual or diffuse disease Our group recently demonstrated the feasibility of pullback pressure gradient PPG derived from virtual Quantitative Flow Ratio QFR pullback curve which is an index of atherosclerosis functional pattern and can be used to epitomize the pathophysiological pattern of CAD as focal or diffuse
In this regard the current study will investigate the incremental value of PPG added to QFR haemodynamic assessment in ischemia-causing vessels received PCI in predicting adverse outcomes
The study cohort is derived from the PANDA-III study Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in Real-World Practice NCT02017275 In this cohort vessels with measurable QFR 080 will be included According to the PPG index calculated from QFR virtual pullback curve and treatment strategy chosen the included vessels were divided into three groupsvessels with PCI strategy and low PPG index group A vessels with PCI strategy with high PPG index group B and vessels with conservative strategy group C and 2-year clinical outcomes for each group will be compared
In this regard the current study will investigate the incremental value of PPG added to QFR haemodynamic assessment in ischemia-causing vessels received PCI in predicting adverse outcomes
The study cohort is derived from the PANDA-III study Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in Real-World Practice NCT02017275 In this cohort vessels with measurable QFR 080 will be included According to the PPG index calculated from QFR virtual pullback curve and treatment strategy chosen the included vessels were divided into three groupsvessels with PCI strategy and low PPG index group A vessels with PCI strategy with high PPG index group B and vessels with conservative strategy group C and 2-year clinical outcomes for each group will be compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None