Radiographic imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)

Radiographic imaging Validation and EvALuation for Angio iFR (ReVEAL iFR) - ReVEAL iFR

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49764

Enrollment

108

Registered

2019-07-15

Start date

2020-01-09

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. *18 years old 2. At least 1 de-novo lesion in 1 or more major epicardial vessels of 40-90% angiographic stenosis with a reference vessel size *2.5mm in the diseased segment by visual estimate 3. Able and willing to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Presenting with an acute coronary syndrome (ACS), or documented ACS within 4 weeks prior to the scheduled index procedure 2. Cardiogenic shock (sustained (>10 min) systolic blood pressure

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of the image-derived iFR and FFR estimate for a given lesion compared to the corresponding invasive iFR and FFR yields a sensitivity * 75% and specificity * 80%	—

Secondary

Measure	Time frame
* Diagnostic agreement between the angiographic derived iFR/FFR estimate and the reference invasive measure for the same lesion is within the inherent measurement variability * Superior specificity of the iFR/FFR estimate over visual determination of stenosis severity based on the angiogram alone (i.e., 50% diameter stenosis) Inter- and intra-observer diagnostic and measurement agreement between repeated estimates made by the medical software device for a given lesion * Diagnostic agreement measures: * Diagnostic accuracy * Positive (PPV) and negative predictive values (NPV) * Area under the Received Operating Characteristics (ROC) curve (AUC) * Positive and negative likelihood ratios * Diagnostic odds ratio	—

Measure

Time frame

* Diagnostic agreement between the angiographic derived iFR/FFR estimate and the reference invasive measure for the same lesion is within the inherent measurement variability * Superior specificity of the iFR/FFR estimate over visual determination of stenosis severity based on the angiogram alone (i.e., *50% diameter stenosis) * Inter- and intra-observer diagnostic and measurement agreement between repeated estimates made by the medical software device for a given lesion * Diagnostic agreement measures: * Diagnostic accuracy * Positive (PPV) and negative predictive values (NPV) * Area under the Received Operating Characteristics (ROC) curve (AUC) * Positive and negative likelihood ratios * Diagnostic odds ratio

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Countries

Netherlands

Outcome results