Validation Of Quantitative Flow Ratio (QFR) - Derived Virtual Angioplasty
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 5
- Primary Endpoint
- Numerical agreement between predicted post PCI QFR (residual QFR) and post PCI dPR RFR-FFR, as well as direct QFR post-PCI mesurement.
Study Overview
Brief Summary
Prospective intervention study to assess the accuracy of the predicted QFR-derived virtual angioplasty compared to hyperaemic and non-hyperaemic pressure-wire derived indexes after PCI, as well as with QFR post-PCI.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients submitted to a coronary angiogram with at least one non-left main stable coronary stenosis with PCI indication.
Exclusion Criteria
- •Severe stenosis of the left main coronary artery.
- •Patients admitted with ST-elevation myocardial infarction.
- •Culprit lesions in Non-ST-Elevation Acute Coronary Syndromes (NSTEACS) patients.
- •Unability to identify the culprit lesion in NSTE-ACS patients.
Arms & Interventions
QFR Intervention
Patients submitted to a coronary angiogram with at least one non-left main stable coronary stenosis between 50 and 90% and PCI indication with paired assessment of QFR, dFR, RFR and FFR, before and after PCI once informed consent is provided.
Intervention: Quantitative Flow Ratio (QFR) measurement (Diagnostic Test)
Outcomes
Primary Outcomes
Numerical agreement between predicted post PCI QFR (residual QFR) and post PCI dPR RFR-FFR, as well as direct QFR post-PCI mesurement.
Time Frame: 1 hour
Secondary Outcomes
- Specificity(1 hour)
- Summary of the receiver-operator characteristics curve (sROC)(1 hour)
- Negative predictive value(1 hour)
- Identification of independent predictors for increased predicted postPCI QFR (residual QFR) and post PCI dPR-RFR-FFR.(1 hour)
- Negative likelihood ratio(1 hour)
- Sensitivity(1 hour)
- Positive likelihood ratio(1 hour)
- Positive predictive value(1 hour)
Investigators
Carlos Baladron, PhD
Research Coordinator, Cardiology
Hospital Clínico Universitario de Valladolid