Status:
UNKNOWN
RFR and FFR for the the Prediction of Post-PCI Results
Lead Sponsor:
Johannes Gutenberg University Mainz
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The aim of this study is to record hemodynamic pullback information using continuous resting full-cycle flow ratio (RFR) and fractional flow reserve (FFR) in patients with diffuse coronary artery dise...
Detailed Description
The study of the hemodynamic relevance of coronary stenoses is a well-validated method to identify coronary lesions to be treated. A number of studies show that FFR-guided PCI is superior to angiograp...
Eligibility Criteria
Inclusion
- Patients must meet ALL of the inclusion criteria:
- Clinical indication for elective percutaneous coronary intervention of a stenosis \>40% and \<90% with clinical indication to percutaneous intervention (PCI) requiring functional assessment. Note: the decision to perform functional assessment will have to be taken before, and independently of, the inclusion and randomization in the study.
- Documented heart team (when applicable, as per guidelines) decision for revascularization via PCI
- Patient ≥18 years old
Exclusion
- Patients will be excluded if ANY of the exclusion criteria is met:
- Cardiogenic shock
- Any contraindication to PCI according to guidelines
- Presence of a coronary artery bypass grafting (CABG) in the territory under study
- Culprit vessels in patients with ST-segment elevation myocardial infarction (STEMI)
- TIMI (Thrombolysis in Myocardial Infarction) flow grade \< 3
- Lesion severity \> 90% by visual assessment
- Presence of thrombus
- Participation in another randomized interventional study
- Patient unable to give informed consent
- Women of child-bearing potential or lactating
Key Trial Info
Start Date :
May 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 10 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04417634
Start Date
May 10 2020
End Date
June 10 2025
Last Update
September 28 2023
Active Locations (1)
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1
Center of Cardiology, Cardiology I, university hospital Mainz
Mainz, Rhineland-Palatinate, Germany, 55131