The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses (DEFINE REAL)

Volcano

Status: Completed

Conditions: Coronary Disease

Treatments: Device: iFR/FFR

Study type: Observational

Funder types: Industry

Identifiers

NCT02281110

2014-CV-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

iFR/FFR assessment

Description:

Patients enrolled into this prospective registry will be derived from Stable Coronary Artery disease or Acute Coronary Syndrome (ACS) population undergoing cardiac catheterization. Patients with ACS may be evaluated by functional assessment in the non-culprit stenosis during the index PCI revascularization or in a staged procedure. The registry will enroll patients in whom physiological assessment (iFR/FFR) is particularly helpful in identifying haemodynamically significant stenosis: MVD patients defined by patients with lesions \> 40% and \<100% in 2 or more vessels.

Treatment:

Device: iFR/FFR