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Clinical Trials in France / NCT04789317
Active, not recruiting Observational

Pullback Pressure Gradient (PPG) Global Registry

NCT04789317 · tracked via the Priya Life Science France tracker
Sponsor
VZW Cardiovascular Research Center Aalst
Phase
Observational
Started
2020-12-23
Last updated
2024-10-15

Condition(s) studied

Chronic Coronary InsufficiencyNon ST Elevation Myocardial Infarction

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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 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

Primary outcome measure(s)

  • Predictive capacity of the PPG index for post-PCI FFR. — 1 year
    Describe the relationship between pre PCI PPG and post-PCI FFR

Trial sites (23)

FacilityCityRegionStatus
Stanford University Stanford California
St Francis Hospital and Heart Center New York New York
Memorial Hermann Texas Medical Center Texas City Texas
Monash Medical Center Melbourne Australia
Concord Repatriation General Hospital Sydney Australia
OLV Aalst Aalst Belgium
Aalborg University Hospital Aalborg Denmark
Aarhus University Hospital Aarhus Denmark
Righospitalet Copenhagen Denmark
Institut Arnault Tzanck Nice France
Ferrara University Ferrara Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy
Aichi University Aichi Japan
Gifu Heart Center Gifu Japan
Showa University Hospital Tokyo Japan
Tokyo D Tower Hospital Tokyo Japan
Catharina Ziekenhuis Eindhoven Netherlands
Radboud UMC Nijmegen Netherlands
Hospital Clinico San Carlos Madrid Spain
Hospital Universitario de La Princesa Madrid Spain
Karolinska Institutet Stockholm Sweden
CHUV Lausanne Switzerland
Guy and St Thomas NHS Foundation Trust London United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04789317 on ClinicalTrials.gov ↗ ← All trials in France