Chronic Coronary InsufficiencyPPG GlobalNCT04789317
Pullback Pressure Gradient (PPG) Global Registry
An observational study of Chronic Coronary Insufficiency and Non ST Elevation Myocardial Infarction, run by VZW Cardiovascular Research Center Aalst at 23 sites in 12 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Coronary Insufficiency, Non ST Elevation Myocardial Infarction
- How many people
- 982 participants
- Where
- 23 sitesin 12 countries
- Study dates
- 23 Dec 2020to 31 Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with stable coronary artery disease or stabilized acute coronary syndrome and indication for hemodynamic assessment by FFR and subsequent confirmation of significant epicardial CAD assessed by an invasive FFR measurement ≤0.80.
Who may be able to join
- Consecutive patients with stable coronary artery disease or stabilized acute coronary syndrome and invasive FFR measurement ≤0.80.
Who cannot join
- Angiographic exclusion criteria
- Ostial lesions.
- Severe vessel tortuosity.
- Vessel rewiring deemed 'difficult' by the operator.
- Bifurcation with planned two-stent strategy.
- NSTEMI culprit vessel.
Show all 10Show fewer
- STEMI
- Uncontrolled or recurrent ventricular tachycardia.
- Hemodynamic instability
- Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2
Trial locations and contacts
23 sites in 12 countries.
23 sites in 12 countries
Japan4 sites
Aichi University
Aichi
Gifu Heart Center
Gifu
Showa University Hospital
Tokyo
Tokyo D Tower Hospital
Tokyo
United States3 sites
St Francis Hospital and Heart Center
New York, New York, 11576
Stanford University
Stanford, California, 94305
Memorial Hermann Texas Medical Center
Texas City, Texas, 77030
Denmark3 sites
Aalborg University Hospital
Aalborg
Aarhus University Hospital
Aarhus
Righospitalet
Copenhagen
Australia2 sites
Monash Medical Center
Melbourne
Concord Repatriation General Hospital
Sydney
Italy2 sites
Ferrara University
Ferrara
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome
Spain2 sites
Hospital Clinico San Carlos
Madrid
Hospital Universitario de La Princesa
Madrid
About this study
Official title: Pullback Pressure Gradient (PPG) Global Registry: Prospective Evaluation of the Impact of the PPG Index on Clinical Decision Making and Outcomes
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.
Read the 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.
- Keywords
- FFR, PPG, PCI
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stable CAD or stabilized NSTEMI (ACS) with significant epicardial lesions defined as FFR≤0.80. | The PPG Global Registry an investigator-initiated, observational, multicenter study of patients with an indication for PCI based on coronary angiography and FFR ≤0.80. After confirmation of intention to treat with PCI, a manual pullback with PPG analysis will be performed. A second level of decision making is then performed concerning PCI, coronary artery bypass grafting (CABG) or medical therapy (OMT). Patients will undergo PCI at operator discretion and post-PCI FFR will be measured. Clinical follow-up will be performed at 1, 2 and 3 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive capacity of the PPG index for post-PCI FFR.
Describe the relationship between pre PCI PPG and post-PCI FFR
Measured: 1 year
Secondary outcomes (2)
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
Measured: 3 years after completion of inclusion
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
Measured: 1 years after completion of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start23 Dec 2020
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Coronary InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 982 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- VZW Cardiovascular Research Center Aalst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Collet, MD PhD, Principal investigator, OLV Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789317
- Sponsor's protocol ID
- CRI050
- Acronym
- PPG Global
- Status last verified
- Sep 2024
- First submitted
- 26 Feb 2021
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31582137Hada M, Mizukami T, Ikeda K, Munhoz D, Brouwers S, Sonck J, Matsuo H, Shinke T, Ando H, Ko B, Biscaglia S, Rivero F, Engstrom T, Arslani K, Leone AM, Galante D, van Nunen LX, Fearon WF, Christiansen EH, Fournier S, Desta L, Yong A, Adjedj J, Escaned J, Nakayama M, Eftekhari A, Zimmermann FM, Sakai K, Storozhenko T, da Costa BR, Campo G, Berry C, Collison D, Johnson T, Amano T, Perera D, Jeremias A, Ali Z, De Bruyne B, Barbato P, Corradetti S, Stalikas N, Kechichian A, Bouisset F, Kakuta T, Johnson NP, Collet C. Impact of Sex on Residual Angina After Percutaneous Coronary Interventions. Catheter Cardiovasc Interv. 2026 Mar;107(4):987-996. doi: 10.1002/ccd.70419. Epub 2025 Dec 17.
PubMed 41408672Collet C, Munhoz D, Mizukami T, Sonck J, Matsuo H, Shinke T, Ando H, Ko B, Biscaglia S, Rivero F, Engstrom T, Arslani K, Leone AM, van Nunen LX, Fearon WF, Christiansen EH, Fournier S, Desta L, Yong A, Adjedj J, Escaned J, Nakayama M, Eftekhari A, Zimmermann FM, Sakai K, Storozhenko T, da Costa BR, Campo G, West NEJ, De Potter T, Heggermont W, Buytaert D, Bartunek J, Berry C, Collison D, Johnson T, Amano T, Perera D, Jeremias A, Ali Z, Pijls NHJ, De Bruyne B, Johnson NP. Influence of Pathophysiologic Patterns of Coronary Artery Disease on Immediate Percutaneous Coronary Intervention Outcomes. Circulation. 2024 Aug 20;150(8):586-597. doi: 10.1161/CIRCULATIONAHA.124.069450. Epub 2024 May 14.
PubMed 38742491Munhoz D, Collet C, Mizukami T, Yong A, Leone AM, Eftekhari A, Ko B, da Costa BR, Berry C, Collison D, Perera D, Christiansen EH, Rivero F, Zimmermann FM, Ando H, Matsuo H, Nakayama M, Escaned J, Sonck J, Sakai K, Adjedj J, Desta L, van Nunen LX, West NEJ, Fournier S, Storozhenko T, Amano T, Engstrom T, Johnson T, Shinke T, Biscaglia S, Fearon WF, Ali Z, De Bruyne B, Johnson NP. Rationale and design of the pullback pressure gradient (PPG) global registry. Am Heart J. 2023 Nov;265:170-179. doi: 10.1016/j.ahj.2023.07.016. Epub 2023 Aug 21.
PubMed 37611857Achim A, Johnson NP, Liblik K, Burckhardt A, Krivoshei L, Leibundgut G. Coronary steal: how many thieves are out there? Eur Heart J. 2023 Aug 7;44(30):2805-2814. doi: 10.1093/eurheartj/ehad327.
PubMed 37264699
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pullback Pressure Gradient (PPG) Global Registry: Prospective Evaluation of the Impact of the PPG Index on Clinical Decision Making and Outcomes
- ClinicalTrials.gov ID
- NCT04789317
- Acronym / sponsor ID
- PPG Global / CRI050
- Keywords
- FFR, PPG, PCI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 982 participants (estimated)
- Lead sponsor
- VZW Cardiovascular Research Center AalstUniversity, hospital or other
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stable CAD or stabilized NSTEMI (ACS) with significant epicardial lesions defined as FFR≤0.80. | – | –The PPG Global Registry an investigator-initiated, observational, multicenter study of patients with an indication for PCI based on coronary angiography and FFR ≤0.80. After confirmation of intention to treat with PCI, a manual pullback with PPG analysis will be performed. A second level of decision making is then performed concerning PCI, coronary artery bypass grafting (CABG) or medical therapy (OMT). Patients will undergo PCI at operator discretion and post-PCI FFR will be measured. Clinical follow-up will be performed at 1, 2 and 3 years. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with stable coronary artery disease or stabilized acute coronary syndrome and indication for hemodynamic assessment by FFR and subsequent confirmation of significant epicardial CAD assessed by an invasive FFR measurement ≤0.80.
Key inclusion criteria (1 listed)
- Consecutive patients with stable coronary artery disease or stabilized acute coronary syndrome and invasive FFR measurement ≤0.80.
Key exclusion criteria (10 listed)
- Angiographic exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive capacity of the PPG index for post-PCI FFR.
Time frame: 1 year
Describe the relationship between pre PCI PPG and post-PCI FFR
2 secondary outcomes
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.
Time frame: 3 years after completion of inclusion
Difference between baseline and 12 month follow-up in the Seattle Angina Questionnaire (SAQ) stratified by PPG index.
Time frame: 1 years after completion of inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 31582137Collet 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.
- Derived from this study: PubMed 41408672Hada M, Mizukami T, Ikeda K, Munhoz D, Brouwers S, Sonck J, Matsuo H, Shinke T, Ando H, Ko B, Biscaglia S, Rivero F, Engstrom T, Arslani K, Leone AM, Galante D, van Nunen LX, Fearon WF, Christiansen EH, Fournier S, Desta L, Yong A, Adjedj J, Escaned J, Nakayama M, Eftekhari A, Zimmermann FM, Sakai K, Storozhenko T, da Costa BR, Campo G, Berry C, Collison D, Johnson T, Amano T, Perera D, Jeremias A, Ali Z, De Bruyne B, Barbato P, Corradetti S, Stalikas N, Kechichian A, Bouisset F, Kakuta T, Johnson NP, Collet C. Impact of Sex on Residual Angina After Percutaneous Coronary Interventions. Catheter Cardiovasc Interv. 2026 Mar;107(4):987-996. doi: 10.1002/ccd.70419. Epub 2025 Dec 17.
- Derived from this study: PubMed 38742491Collet C, Munhoz D, Mizukami T, Sonck J, Matsuo H, Shinke T, Ando H, Ko B, Biscaglia S, Rivero F, Engstrom T, Arslani K, Leone AM, van Nunen LX, Fearon WF, Christiansen EH, Fournier S, Desta L, Yong A, Adjedj J, Escaned J, Nakayama M, Eftekhari A, Zimmermann FM, Sakai K, Storozhenko T, da Costa BR, Campo G, West NEJ, De Potter T, Heggermont W, Buytaert D, Bartunek J, Berry C, Collison D, Johnson T, Amano T, Perera D, Jeremias A, Ali Z, Pijls NHJ, De Bruyne B, Johnson NP. Influence of Pathophysiologic Patterns of Coronary Artery Disease on Immediate Percutaneous Coronary Intervention Outcomes. Circulation. 2024 Aug 20;150(8):586-597. doi: 10.1161/CIRCULATIONAHA.124.069450. Epub 2024 May 14.
- Derived from this study: PubMed 37611857Munhoz D, Collet C, Mizukami T, Yong A, Leone AM, Eftekhari A, Ko B, da Costa BR, Berry C, Collison D, Perera D, Christiansen EH, Rivero F, Zimmermann FM, Ando H, Matsuo H, Nakayama M, Escaned J, Sonck J, Sakai K, Adjedj J, Desta L, van Nunen LX, West NEJ, Fournier S, Storozhenko T, Amano T, Engstrom T, Johnson T, Shinke T, Biscaglia S, Fearon WF, Ali Z, De Bruyne B, Johnson NP. Rationale and design of the pullback pressure gradient (PPG) global registry. Am Heart J. 2023 Nov;265:170-179. doi: 10.1016/j.ahj.2023.07.016. Epub 2023 Aug 21.
- Derived from this study: PubMed 37264699Achim A, Johnson NP, Liblik K, Burckhardt A, Krivoshei L, Leibundgut G. Coronary steal: how many thieves are out there? Eur Heart J. 2023 Aug 7;44(30):2805-2814. doi: 10.1093/eurheartj/ehad327.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Collet, MD PhD principal investigator
OLV Hospital
23 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Coronary Insufficiency and Non ST Elevation Myocardial Infarction, run by VZW Cardiovascular Research Center Aalst at 23 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Japan, United States, Denmark, Australia, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive capacity of the PPG index for post-PCI FFR. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04789317, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.