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

Sponsor

Samsung Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04265443

Collaborator

Inje University (Other), Ulsan University Hospital (Other), Sejong General Hospital (Other), Chosun University Hospital (Other)

588

Enrollment

Locations

115.6

Anticipated Duration (Months)

117.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease	Device: Percutaneous coronary intervention

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 Design

Study Type:

Observational

Actual Enrollment :

588 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 13, 2013

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	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	Device: Percutaneous coronary intervention PCI was performed using 2nd generation DES

Arm

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

Device: Percutaneous coronary intervention

PCI was performed using 2nd generation DES

Outcome Measures

Primary Outcome Measures

Target Vessel Failure [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 Outcome Measures

independent predictors for target-vessel failure [2 years after index procedure]
independent predictors for target-vessel failure by univariate and multivariate analysis will be performed.
delta FFR per unit time [At the time of index procedure]
delta FFR per unit time in pre-PCI pullback recording
Relative percent increase of physiologic indices [At the time of index procedure]
Percent increase of FFR or non-hyperemic pressure ratios

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Sejong General Hospital	Bucheon	Korea, Republic of
2	Inje University Ilsan Paik Hospital	Goyang-si	Korea, Republic of
3	Chosun University Hospital	Gwangju	Korea, Republic of
4	Samsung Medical Center	Seoul	Korea, Republic of
5	Ulsan Medical Center	Ulsan	Korea, Republic of