Status:
COMPLETED
The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses
Lead Sponsor:
Volcano Corporation
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 und...
Detailed 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 aver...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT02281110
Start Date
July 1 2014
End Date
December 1 2015
Last Update
May 10 2016
Active Locations (1)
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1
Volcano Europe BVBA/SPRL
Zaventem, Belgium, 1930