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

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

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