Pullback Pressure Gradient (PPG) Global Registry

NCT04789317 · tracked via the Priya Life Science Denmark 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

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)

Facility	City	Region
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 Denmark