Status:
COMPLETED
Pressure Guidewire Comparison
Lead Sponsor:
Lokien van Nunen
Collaborating Sponsors:
Cavis Technologies AB
Conditions:
Coronary Artery Disease
Myocardial Ischemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Fractional flow reserve (FFR) is the current gold standard for correct decision making with respect to revascularization in the catheterization laboratory. FFR is measured by using a pressure guidewir...
Detailed Description
FFR is a lesion-specific pressure-derived index of functional severity, defined as the maximum myocardial blood flow in the presence of an epicardial stenosis compared with the maximum flow in the hyp...
Eligibility Criteria
Inclusion
- Age 18-80 years
- Scheduled to undergo invasive FFR measurement
- Coronary artery lesions located in the proximal or mid part of the coronary artery
- Reference diameter of at least 2.0mm
Exclusion
- Severe aortic valve stenosis
- known conduction disturbances (second- or third-degree AV block)
- acute myocardial infarction (CK \>1,000 U/L less than 5 days ago)
- bradycardia (less than 45 beats/min)
- severe hypotension
- extremely tortuous or calcified coronary arteries precluding FFR measurement
- history of severe asthma
- pregnancy
- inability to provide informed consent.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04802681
Start Date
December 1 2021
End Date
January 19 2023
Last Update
July 17 2023
Active Locations (1)
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1
Catharina Hospital
Eindhoven, North Brabant, Netherlands, 5623EJ