Pullback Pressure Gradient (PPG) Global Registry
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
🗓️ Study Start (Actual) 23 December 2020
🗓️ Primary Completion (Estimated) 31 December 2022
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 982
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Texas City, Texas, United States
📍 Melbourne, Clayton VIC, Australia
📍 Aalst, Oost-Vlaanderen, Belgium
📍 Milan, Italy
📍 Shinagawa, Tokyo, Japan
📍 Glasgow, United Kingdom
📍 London, United Kingdom

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 100 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 26 February 2021
  • First Submitted that Met QC Criteria 4 March 2021
  • First Posted 9 March 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 March 2021
  • Last Update Posted 9 March 2021
  • Last Verified March 2021