Clinical trial NCT04200469: Validation Of Quantitative Flow Ratio (QFR) - Derived Virtual Angioplasty
Official title: Validation Of Quantitative Flow Ratio (QFR) - Derived Virtual Angioplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Occlusion
Keywords: Quantitative Flow Ratio
QFR
Percutaneous Coronary Intervention
Lead sponsor: Hospital Clínico Universitario de Valladolid
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Numerical agreement between predicted post PCI QFR (residual QFR) and post PCI dPR RFR-FFR, as well as direct QFR post-PCI mesurement.
timeFrame: 1 hour
Secondary outcomes:
measure: Sensitivity
timeFrame: 1 hour
measure: Specificity
timeFrame: 1 hour
measure: Summary of the receiver-operator characteristics curve (sROC)
timeFrame: 1 hour
measure: Negative predictive value
timeFrame: 1 hour
measure: Positive predictive value
timeFrame: 1 hour
measure: Positive likelihood ratio
timeFrame: 1 hour
measure: Negative likelihood ratio
timeFrame: 1 hour
measure: Identification of independent predictors for increased predicted postPCI QFR (residual QFR) and post PCI dPR-RFR-FFR.
timeFrame: 1 hour
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Complejo Hospitalario Universitario, Santiago de Compostela
state: La Coruña
city: Lugo
country: Spain
facility: Hospital de Lugo
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
References:
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