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

Hospital Clínico Universitario de Valladolid

Status: Unknown

Conditions: Coronary Occlusion

Treatments: Diagnostic Test: Quantitative Flow Ratio (QFR) measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT04200469

CASVE-PI-19-1515

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

QFR Intervention

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Quantitative Flow Ratio (QFR) measurement