Status:
UNKNOWN
Diagnostic Agreement of iFR and QFR.
Lead Sponsor:
Contilia Clinical Research Institute
Conditions:
Fractional Flow Reserve, Myocardial
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
A Prospective, observational, single center diagnostic study to investigate the the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting.
Detailed Description
During coronary angiography, intermediate stenoses can not be adequately assessed by visual assessment alone. It is necessary to evaluate the functional significance to guide their treatment. Fractio...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age \> 18 with symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing)
- Patients witch semi recent (\>3 days) acute coronary syndromes can be included but only for the non-culprit vessels and outside of primary intervention during acute myocardial infarction.
- Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
- Eligible for coronary angiography and/or percutaneous coronary intervention
- Coronary artery disease with at least 1 or more visually assessed de novo coronary stenosis (30-90% diameter stenosis) in native major epicardial vessel or its branches by coronary angiogram.
- Exclusion criteria:
- Contraindication to adenosine administration
- Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel
Exclusion
Key Trial Info
Start Date :
July 18 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2018
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03420131
Start Date
July 18 2017
End Date
October 1 2018
Last Update
February 5 2018
Active Locations (1)
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1
Contilia heart and vascular center
Essen, North Rhine-Westphalia, Germany, 45138