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Clinical Trials/NCT04684043
NCT04684043
Unknown
Not Applicable

Prognostic Implications of Physiologic Investigation After Revascularization With Stent

Bon-Kwon Koo1 site in 1 country5,100 target enrollmentMay 16, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Disease
Sponsor
Bon-Kwon Koo
Enrollment
5100
Locations
1
Primary Endpoint
Target vessel failure
Last Updated
5 years ago

Overview

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 0.86 to 0.96, 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.

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'.

Registry
clinicaltrials.gov
Start Date
May 16, 2020
End Date
February 28, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bon-Kwon Koo
Responsible Party
Sponsor Investigator
Principal Investigator

Bon-Kwon Koo

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Target vessel failure

Time Frame: 2 years

A composite of cardiac death, target vessel myocardial infarction and target vessel revascularization

Secondary Outcomes

  • Cardiac death or myocardial infarction(2 years)
  • Target vessel myocardial infarction(2 years)
  • Target vessel revascularization(2 years)

Study Sites (1)

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