- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04265443
Prognostic Perspective of Invasive Hyperemic and Non-Hyperemic Physiologic Indices Measured After Percutaneous Coronary Intervention (PERSPECTIVEPCI)
Prognostic Perspective of Invasive Hyperemic and Non-Hyperemic Physiologic Indices Measured After Percutaneous Coronary Intervention (PERSPECTIVE-PCI)
Coronary physiologic assessments by the pressure-derived fractional flow reserve (FFR) have become standard methods for identifying hemodynamic deprivation in coronary arterial stenosis for evidence-based percutaneous coronary intervention (PCI). Invasive physiologic indices-guidance enables on-site real time assessment for functional significance of epicardial coronary stenosis and the use of those indices has shown to be effective to guide treatment decision. Several studies further support the role of post-PCI FFR measurement as a functional marker of residual disease after PCI and prognostic indicator of patients. Although optimal cut-off values of post-PCI FFR varied across studies, an inverse relationship between post-PCI FFR and the risk of future clinical events have been reported consistently.
Recently, non-hyperemic pressure ratios (NHPRs) have been introduced in clinical practice. Although there are several different NHPRs, previous studies consistently indicated that those NHPRs shares similar diagnostic performance and prognostic implications. Nevertheless, few reports were available for clinical relevance of NHPRs in evaluation of post-PCI status.
In this context, we will evaluate the physiologic characteristics and prognostic implication of post-PCI NHPRs and compare with those of post-PCI FFR in patients who underwent angiographically successful PCI with 2nd generation drug-eluting stent implantation (DES).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients who diagnosed significant coronary artery disease and treated by 2nd generation DES with post-PCI physiologic evaluation would be enrolled.
Invasive physiologic assessment including recording of resting pressure trecing would be required at the baseline and at the end of index PCI procedure. PCI procedure would be performed upon local routine. Any available 2nd generation DES could be used. Web-based electronic-case record form (CRF) system will be used for collecting data. All data will be handled and analyzed by blind fashion at independent core lab. 2-year clinical outcome after index procedure will be analyzed.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Bucheon, Korea, Republic of
- Sejong General Hospital
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Goyang-si, Korea, Republic of
- Inje University Ilsan Paik Hospital
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Gwangju, Korea, Republic of
- Chosun university hospital
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Seoul, Korea, Republic of
- Samsung Medical Center
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Ulsan, Korea, Republic of
- Ulsan Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- any patient meets eligible criteria who underwent PCI with DES followed by invasive physiologic assessment at the index procedure
- available both post-PCI resting pressure tracing and FFR
Exclusion Criteria:
- culprit vessel of acute coronary syndrome
- failed achieving TIMI 3 flow at the end of PCI
- left ventricular ejection fraction <30%
- graft vessel
- collateral feeder
- in-stent restenosis
- primary myocardial or valvular heart disease
- in patient whose life expectancy less than 2 years
- visible thrombus of target vessel segment
- unmeasured post-PCI resting pressure tracings
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Post PCI state
The study population of this study underwent percutaneous coronary intervention(PCI) with 2nd generation drug-eluting stent (DES) and measured invasive physiologic indices after PCI
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PCI was performed using 2nd generation DES
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Target Vessel Failure
Time Frame: 2 years after index procedure
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a composite of cardiac death, clinically-driven target vessel-related myocardial infarction, and clinically-driven target vessel revascularization.
The target vessel will be defined as the treated vessel with 2nd generation DES which was assessed by post stent fractional flow reserve.
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2 years after index procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
independent predictors for target-vessel failure
Time Frame: 2 years after index procedure
|
independent predictors for target-vessel failure by univariate and multivariate analysis will be performed.
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2 years after index procedure
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delta FFR per unit time
Time Frame: At the time of index procedure
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delta FFR per unit time in pre-PCI pullback recording
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At the time of index procedure
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Relative percent increase of physiologic indices
Time Frame: At the time of index procedure
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Percent increase of FFR or non-hyperemic pressure ratios
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At the time of index procedure
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- POSTPCI_NHPRs20200206
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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