MedPath

Validation Of Quantitative Flow Ratio (QFR) - Derived Virtual Angioplasty

Not Applicable
Conditions
Coronary Occlusion
Registration Number
NCT04200469
Lead Sponsor
Hospital Clínico Universitario de Valladolid
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
100
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Numerical agreement between predicted post PCI QFR (residual QFR) and post PCI dPR RFR-FFR, as well as direct QFR post-PCI mesurement.1 hour
Secondary Outcome Measures
NameTimeMethod
Summary of the receiver-operator characteristics curve (sROC)1 hour
Negative predictive value1 hour
Identification of independent predictors for increased predicted postPCI QFR (residual QFR) and post PCI dPR-RFR-FFR.1 hour
Specificity1 hour
Negative likelihood ratio1 hour
Sensitivity1 hour
Positive likelihood ratio1 hour
Positive predictive value1 hour

Trial Locations

Locations (5)

Complejo Hospitalario Universitario, Santiago de Compostela

🇪🇸

Santiago De Compostela, La Coruña, Spain

Hospital de Lugo

🇪🇸

Lugo, Spain

Hospital Clínico San Carlos

🇪🇸

Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

🇪🇸

Murcia, Spain

Hospital Clínico Universitario de Valladolid

🇪🇸

Valladolid, Spain

Complejo Hospitalario Universitario, Santiago de Compostela
🇪🇸Santiago De Compostela, La Coruña, Spain
José R Rumoroso, MD
Contact
Mario Sadaba
Sub Investigator

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.