Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04684043
Status:
UNKNOWN
Last Update Posted:
2021-02-26
First Post:
2020-12-22
Brief Title:
Prognostic Implications of Physiologic Investigation After Revascularization With Stent
Sponsor:
Bon-Kwon Koo
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Prognostic Implications of Physiologic Investigation After Revascularization With Stent
Status:
UNKNOWN
Status Verified Date:
2021-02
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:
POST-PCI FLOW
Brief Summary:
Percutaneous coronary intervention PCI is a standard treatment strategy for coronary artery disease CAD With the presence of myocardial ischemia PCI reduces the risks of death myocardial infarction MI and revascularization compared to medical therapy However the risk of future clinical events remains high and about 10 of patients experienced further cardiovascular events after PCI Several factors are associated with these poor outcomes Well known patient-related risk factors are diabetes mellitus chronic kidney disease left ventricular dysfunction previous MI and presentation with the acute coronary syndrome Procedure-related factors such as stent underexpension malapposition edge dissection the number of the used stent and total stent length are also related to poor prognosis after PCI Recent studies reported that fractional flow reserve FFR after coronary stenting or post PCI FFR was associated with future clinical outcomes after PCI and low post PCI FFR value was associated with procedural factors However optimal cut-off values of post-PCI FFR ranged widely from 086 to 096 and some study reported the limited prognostic value of post-PCI FFR This might result from differences in study populations the definition of outcomes type of stent used and distribution of included vessels among previous studies
To establish the clinical relevance of post-PCI FFR and to evaluate the useful cut-off value of post-PCI FFR in daily practice investigators planned to incorporate all previous evidence of post-PCI FFR by collaboration with international researchers
To establish the clinical relevance of post-PCI FFR and to evaluate the useful cut-off value of post-PCI FFR in daily practice investigators planned to incorporate all previous evidence of post-PCI FFR by collaboration with international researchers
Detailed Description:
This study population was incorporated from studies which were already published Investigators will incorporate all known registries to the POST-PCI FLOW registry by requesting data from principal investigator of each registry
Investigators will perform systemic review of the previous published data and an updated patient-level meta-analysis of studies including the most recent publications PubMed EMBASE Cochrane Central Register of Controlled Trials the United States National Institutes of Health registry of clinical trials and relevant websites were searched for pertinent published studies The electronic search strategy was complemented by manual examination of references cited by included articles recent reviews editorials and meta-analyses No restrictions were imposed on language study period or sample size Searching key words included post after PCI Percutaneous coronary intervention coronary stenting stenting stent stent implantation FFR and fractional flow reserve
Investigators will perform systemic review of the previous published data and an updated patient-level meta-analysis of studies including the most recent publications PubMed EMBASE Cochrane Central Register of Controlled Trials the United States National Institutes of Health registry of clinical trials and relevant websites were searched for pertinent published studies The electronic search strategy was complemented by manual examination of references cited by included articles recent reviews editorials and meta-analyses No restrictions were imposed on language study period or sample size Searching key words included post after PCI Percutaneous coronary intervention coronary stenting stenting stent stent implantation FFR and fractional flow reserve
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