The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses

Volcano Corporation500 enrolled

Overview

The purpose of this registry is to collect real life information and to document the performance and user friendliness of iFR in daily diagnostic practice and treatment strategies for MVD patients undergoing cardiac catheterization.

The REAL Registry will enroll a maximum of 3,000 patients in approximately 300 sites across multiple European and Middle East countries, where product has received CE approval and is marketed. An average of 10 cases with a maximum of 50 patients will be enrolled per participating site. No follow-up will be performed. The REAL Registry will only collect data during diagnostic angiogram or PCI procedure, when performed.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Coronary Disease

Interventions

iFR/FFRDEVICE

• The Volcano iFR®-FFR option, which is a measurement modality for the Volcano system that provides the capability to make FFR and instantaneous wave-Free Ratio™ (iFR®) measurements (CE-Marked). iFR® is a pressure-derived, hyperemia-free index for the assessment of coronary stenosis relevance. This option consists of an FFR-iFR® specific patient interface module (PIM-FFR) which can be connected to the Volcano system - VOLCANO s5 or s5i™ platform equipped with iFR® option. This PIM-FFR is compatible with all Volcano pressure measurement guide wires.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Over 18 year of age * Willing to participate and able to understand, read and sign the informed consent document before the planned procedure * Eligible for coronary angiography and PCI * Coronary artery disease with at least two or more visually assessed coronary stenoses (greater than 40% diameter stenosis) in native, major epicardial vessel or its branches by coronary angiogram with an indication of physiological assessment. Exclusion Criteria: * Inability to obtain a signed informed consent from potential patient. * Any contraindication for functional assessment as per the instructions per use and determined by the investigator.

Locations (1)

Volcano Europe BVBA/SPRL

Zaventem, Belgium

Outcomes

Primary Outcomes

Hemodynamic severity (Percentage of stenosis properly classified by iFR®)

Percentage of stenosis properly classified by iFR® in terms of hemodynamic severity compare to FFR in MVD patients. Hemodynamic severity will be established with an FFR value \<=0,80.

Time frame: Day 1 (Post-Procedure)

Secondary Outcomes

changes in iFR® and FFR

Changes in iFR® and FFR pre angioplasty and post angioplasty in MVD patients.

Time frame: Day 1 (Post-Procedure)

Changes to decision strategy of revascularization

Percentage of MVD patients in whom the decision strategy of revascularization changed after iFR® compare to the decision based on diagnostic angiogram only.

Time frame: Day 1 (Post-Procedure)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.