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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04200469
Acronym
QIMERA-I
Enrollment
100
Registered
2019-12-16
Start date
2020-01-01
Completion date
2022-01-31
Last updated
2021-09-24

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

Conditions

Coronary Occlusion

Keywords

Quantitative Flow Ratio, QFR, Percutaneous Coronary Intervention

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.

Interventions

DIAGNOSTIC_TESTQuantitative Flow Ratio (QFR) measurement

Quantitative flow ratio (QFR) is a novel approach enabling rapid computation of FFR pullbacks from three-dimensional quantitative coronary angiography (3D-QCA) without using a pressure wire.

Sponsors

Hospital Clínico Universitario de Valladolid
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Sensitivity1 hour
Specificity1 hour
Summary of the receiver-operator characteristics curve (sROC)1 hour
Negative predictive value1 hour
Positive predictive value1 hour
Positive likelihood ratio1 hour
Negative likelihood ratio1 hour
Identification of independent predictors for increased predicted postPCI QFR (residual QFR) and post PCI dPR-RFR-FFR.1 hour

Countries

Spain

Contacts

Primary ContactCarlos Baladron, PhD
icicor@icicor.es+34983420000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026