Pullback Pressure Gradient (PPG) Global Registry

Non ST Elevation Myocardial Infarction Clinical Trial

— PPG Global  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04789317
• Other study ID #: CRI050
• Status: Recruiting
• Start date: December 23, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2021
• Source: VZW Cardiovascular Research Center Aalst
• Contact: Carlos Collet, MD PhD
• Phone: 003253721927
• Email: carloscollet[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 982
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Angiographic exclusion criteria

1. Ostial lesions.

2. Severe vessel tortuosity.

3. Vessel rewiring deemed 'difficult' by the operator.

4. Bifurcation with planned two-stent strategy.

5. NSTEMI culprit vessel.

6. STEMI

7. Uncontrolled or recurrent ventricular tachycardia.

8. Hemodynamic instability

9. Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2

Related Conditions & MeSH terms

• Chronic Coronary Insufficiency
• Infarction
• Myocardial Infarction
• Non ST Elevation Myocardial Infarction
• Non-ST Elevated Myocardial Infarction

Locations

Country	Name	City	State
Australia	Monash Medical Center	Melbourne	Clayton VIC
Belgium	OLV-Aalst	Aalst	Oost-Vlaanderen
Italy	Centro Cardiologico Monzino	Milan
Japan	Showa University Hospital	Shinagawa	Tokyo
United Kingdom	University of Glasgow	Glasgow
United Kingdom	King's College London	London
United States	Memorial Hermann Texas Medical Center	Texas City	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VZW Cardiovascular Research Center Aalst

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Italy,  Japan,  United Kingdom, 

References & Publications (1)

Collet C, Sonck J, Vandeloo B, Mizukami T, Roosens B, Lochy S, Argacha JF, Schoors D, Colaiori I, Di Gioia G, Kodeboina M, Suzuki H, Van 't Veer M, Bartunek J, Barbato E, Cosyns B, De Bruyne B. Measurement of Hyperemic Pullback Pressure Gradients to Characterize Patterns of Coronary Atherosclerosis. J Am Coll Cardiol. 2019 Oct 8;74(14):1772-1784. doi: 10.1016/j.jacc.2019.07.072. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of patients with intended PCI but deferred after PPG calculation.	Assess the influence of pullback and PPG on identification of patterns of CAD and change in treatment strategy	1 year
Primary	Predictive capacity of the PPG index for post-PCI FFR.	Describe the relationship between pre PCI PPG and post-PCI FFR	1 year
Secondary	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.	Assess whether the PPG and identification of CAD endo-type has a relationship with per and post-procedure events	3 years after completion of inclusion
Secondary	Difference between baseline and 12 month follow-up in the Seattle Angina Questionnaire (SAQ) stratified by PPG index.	Assess the relationship with symptoms assessed by the SAQ and PPG and persistent/recurrent angina post-PCI	1 years after completion of inclusion