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Pullback Pressure Gradient (PPG) Global Registry

Pullback Pressure Gradient (PPG) Global Registry: Prospective Evaluation of the Impact of the PPG Index on Clinical Decision Making and Outcomes

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04789317
Acronym
PPG Global
Enrollment
982
Registered
2021-03-09
Start date
2020-12-23
Completion date
2026-12-31
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Coronary Insufficiency, Non ST Elevation Myocardial Infarction

Keywords

FFR, PPG, PCI

Brief summary

The purpose of this study is to determine the predictive capacity of the Pullback Pressure Gradient (PPG) index for post-PCI FFR and to determine the impact of the PPG index on clinical decision making about revascularization and on clinical outcomes.

Detailed description

A Fractional Flow Reserve (FFR) evaluation comprises measurement of a distal single value and a pullback maneuver during hyperemic conditions. The PPGindex is a novel metric derived from the FFR pullback curve.3 This metric complements the distal FFR value by informing the spatial distribution of epicardial resistance (i.e. focal or diffuse) along the coronary vessel. The PPGindex relies on two components: first, the magnitude of pressure drop determined as a maximal pressure gradient over 20 millimeters relative to the total vessel gradient; and second, the length of functional disease relative to total vessel length. These two parameters are weighted equally to provide a metric that ranges from 0 to 1. PPGindex values approaching 1 represent functional focal coronary artery disease (CAD) whereas values close to 0 represent diffuse functional CAD. Until now, the interpretation of the FFR pullback relied on visual assessment. The PPGindex quantifies the pattern of functional CAD and has been shown to predict functionally complete revascularization. Percutaneous revascularization in vessels with high PPGindex is associated with high post-PCI FFR and vast improvement in epicardial conductance whilst PCI in vessels with low PPGindex results in low post-PCI FFR. An curvilinear relationship is observed between PPGindex and functional gain (i.e. FFR post-PCI minus FFR pre-PCI). The PPGindex, therefore, aims to predict the response to PCI in physiological terms. Calculation of the PPGindex is indicated in cases with an FFR≤0.80. FFR pullbacks are performed under hyperemic conditions at a steady pace during manual pullback. A calculation of the PPGindex using the Coroflow console (Coroventis Research Ab, Uppsala, Sweden) is available for online use and computes the PPG value immediately after the pullback maneuver. This software also includes an automated drift correction. The pullback curve is depicted on an dedicated pullback display screen and the pressure gradients are shown per millimeter, allowing correlation between the location of pressure step-ups and the anatomical target for PCI. In summary, we can distinguish three points where FFR influences the clinical decision-making process. First, an FFR ≤0.80 indicates potential benefit of revascularization. Second, the pullback curve assesses disease pattern and PPG index value quantifies it, helping de physician in the decision about treatment options (e.g. PCI, CABG or OMT). And, third, the location of pressure step-ups along the vessels helps plan the PCI strategy with respect to coverage of functional disease. A combined FFR and PPG-guided PCI strategy has the potential to improve patient selection and enhance procedural planning. The purpose of this study is to determine the predictive capacity of the PPG index for post-PCI FFR and to determine the impact of the PPG index on clinical decision making about revascularization and on clinical outcomes.

Interventions

None listed

Sponsors

VZW Cardiovascular Research Center Aalst
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Consecutive patients with stable coronary artery disease or stabilized acute coronary syndrome and invasive FFR measurement ≤0.80.

Exclusion criteria

* Angiographic

Design outcomes

Primary

MeasureTime frameDescription
Predictive capacity of the PPG index for post-PCI FFR.1 yearDescribe the relationship between pre PCI PPG and post-PCI FFR

Secondary

MeasureTime frameDescription
To assess the relationship between baseline PPG index and major adverse cardiovascular events (cardiac death, peri-procedural and spontaneous myocardial infarction and target vessel revascularization) at one, two and three years.3 years after completion of inclusionAssess whether the PPG and identification of CAD endo-type has a relationship with per and post-procedure events
Difference between baseline and 12 month follow-up in the Seattle Angina Questionnaire (SAQ) stratified by PPG index.1 years after completion of inclusionAssess the relationship with symptoms assessed by the SAQ and PPG and persistent/recurrent angina post-PCI

Other

MeasureTime frameDescription
Rate of patients with intended PCI but deferred after PPG calculation.1 yearAssess the influence of pullback and PPG on identification of patterns of CAD and change in treatment strategy

Countries

Australia, Belgium, Denmark, France, Italy, Japan, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026