Comparing RFR and FFR to predict outcomes after heart stenting
Pullback wIth Resting Full-Cycle Flow ratIO or Fractional Flow Reserve for the Prediction of Post-PCI Hemodynamic Outcomes. A Study in Patients With Diffuse Coronary Artery Disease
This study is testing if a new way of measuring blood flow can better predict how patients with coronary artery disease will do after getting heart stents compared to the standard method.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Johannes Gutenberg University Mainz Academic / other |
| Locations | 1 site (Mainz, Rheinland-Pfalz) |
| Trial ID | NCT04417634 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of continuous resting full-cycle flow ratio (RFR) and fractional flow reserve (FFR) in predicting hemodynamic outcomes following percutaneous coronary intervention (PCI) in patients with coronary artery disease. It will compare the accuracy of RFR and FFR gradients in forecasting changes in whole-vessel RFR/FFR after stenting. The study seeks to establish a threshold in the RFR/FFR gradient that can predict pathological outcomes after PCI. By utilizing resting indexes, the study aims to provide a less invasive alternative to traditional methods that require hyperemia.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 and older with a clinical indication for elective PCI of a stenosis between 40% and 90%.
Not a fit: Patients with cardiogenic shock, contraindications to PCI, or severe lesions (>90%) will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction of patient outcomes after heart stenting, enhancing treatment strategies for coronary artery disease.
How similar studies have performed: Previous studies have shown that FFR-guided PCI is superior to angiography-guided PCI, indicating potential success for this novel approach using RFR.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Mainz, Rheinland-Pfalz
- Center of Cardiology, Cardiology I, university hospital Mainz — Mainz, Rheinland-Pfalz, Germany (Recruiting)
Study contacts
- Study coordinator: Tommaso Gori
- Email: tomgori@hotmail.com
- Phone: +491721052846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.