Prognostic Perspective of Invasive Hyperemic and Non-Hyperemic Physiologic Indices Measured After Percutaneous Coronary Intervention (PERSPECTIVEPCI)

October 24, 2022 updated by: Joo Myung Lee, Samsung Medical Center

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

Completed

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

Observational

Enrollment (Actual)

588

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bucheon, Korea, Republic of
        • Sejong General Hospital
      • Goyang-si, Korea, Republic of
        • Inje University Ilsan Paik Hospital
      • Gwangju, Korea, Republic of
        • Chosun university hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Ulsan, Korea, Republic of
        • Ulsan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who diagnosed obstructive coronary artery disease and treated by DES with invasive physiologic evaluation at the index procedure

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
PCI was performed using 2nd generation DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Vessel Failure
Time Frame: 2 years after index procedure
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.
2 years after index procedure

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.
2 years after index procedure
delta FFR per unit time
Time Frame: At the time of index procedure
delta FFR per unit time in pre-PCI pullback recording
At the time of index procedure
Relative percent increase of physiologic indices
Time Frame: At the time of index procedure
Percent increase of FFR or non-hyperemic pressure ratios
At the time of index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 13, 2013

Primary Completion (ACTUAL)

October 1, 2022

Study Completion (ACTUAL)

October 1, 2022

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 8, 2020

First Posted (ACTUAL)

February 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

De-identified patient data will be shared upon reasonable request after discussion in executive committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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