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NCT Number: NCT04265443

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

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).

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Key information

Conditions

Ischemic Heart Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sejong General Hospital, Bucheon-si, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention

Device

PCI was performed using 2nd generation DES

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. delta FFR per unit time

    Time frame: At the time of index procedure

    delta FFR per unit time in pre-PCI pullback recording

  3. Relative percent increase of physiologic indices

    Time frame: At the time of index procedure

    Percent increase of FFR or non-hyperemic pressure ratios

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Chosun University Hospital
  • Inje University Ilsan Paik Hospital
  • Sejong General Hospital
  • Ulsan University Hospital

Registry information

Official study title

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

Acronym: PERSPECTIVEPCI

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2020
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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