Pullback Pressure Gradient (PPG) Global Registry

NCT04789317 | Active Not Recruiting DMC

• 1 other identifier: CRI050
• Study Type: observational
• Target: 982
• Locations: 12 countries
• Sites: 23

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.

Conditions

Chronic Coronary Insufficiency; Non ST Elevation Myocardial Infarction

Keywords

FFR; PPG; PCI

Outcome Measures

Primary Outcomes (1)

• Predictive capacity of the PPG index for post-PCI FFR.

  Describe the relationship between pre PCI PPG and post-PCI FFR

  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.

  3 years after completion of inclusion

• Difference between baseline and 12 month follow-up in the Seattle Angina Questionnaire (SAQ) stratified by PPG index.

  1 years after completion of inclusion

Other Outcomes (1)

• Rate of patients with intended PCI but deferred after PPG calculation.

  1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• Ostial lesions.
• Severe vessel tortuosity.
• Vessel rewiring deemed 'difficult' by the operator.
• Bifurcation with planned two-stent strategy.
• NSTEMI culprit vessel.
• STEMI
• Uncontrolled or recurrent ventricular tachycardia.
• Hemodynamic instability
• Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2

Sponsors & Collaborators

• VZW Cardiovascular Research Center Aalst: lead

Study Sites (23)

Stanford University

Stanford, California, 94305, United States

Location

St Francis Hospital and Heart Center

New York, New York, 11576, United States

Location

Memorial Hermann Texas Medical Center

Texas City, Texas, 77030, United States

Location

Monash Medical Center

Melbourne, Australia

Location

Concord Repatriation General Hospital

Sydney, Australia

Location

OLV Aalst

Aalst, Belgium

Location

Aalborg University Hospital

Aalborg, Denmark

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Righospitalet

Copenhagen, Denmark

Location

Institut Arnault Tzanck

Nice, France

Location

Ferrara University

Ferrara, Italy

Location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy

Location

Aichi University

Aichi, Japan

Location

Gifu Heart Center

Gifu, Japan

Location

Showa University Hospital

Tokyo, Japan

Location

Tokyo D Tower Hospital

Tokyo, Japan

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Radboud UMC

Nijmegen, Netherlands

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Universitario de La Princesa

Madrid, Spain

Location

Karolinska Institutet

Stockholm, Sweden

Location

CHUV

Lausanne, Switzerland

Location

Guy and St Thomas NHS Foundation Trust

London, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 31582137 BACKGROUND

• Hada 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. 2025 Dec 17. doi: 10.1002/ccd.70419. Online ahead of print.

  PMID: 41408672 DERIVED

• Collet 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.

  PMID: 38742491 DERIVED

• Munhoz 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.

  PMID: 37611857 DERIVED

• Achim 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.

  PMID: 37264699 DERIVED

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Carlos Collet, MD PhD

  OLV Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 9, 2021
• Study Start: December 23, 2020
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); AU (2); FR (1); BE (1); ES (2); CH (1); IT (2); SE (1); GB (1); JP (4); DK (3); NL (2)