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

Not Applicable

• Conditions: Coronary Occlusion
• Interventions: Diagnostic Test: Quantitative Flow Ratio (QFR) measurement

• 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

Study Timeline

• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-16
• Study Start: 2020-01-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-31

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

Arm && Interventions

Group	Intervention	Description
QFR Intervention	Quantitative Flow Ratio (QFR) measurement	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Specificity	1 hour
Negative likelihood ratio	1 hour
Sensitivity	1 hour
Positive likelihood ratio	1 hour
Positive predictive value	1 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