Status:
COMPLETED
Diastolic Hyperemia Free Index for Assessment of Moderate Coronary Stenoses
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-90 years
Brief Summary
A total of 106 subjects will be enrolled at up to 3 sites. Initial enrollment will occur at Washington University only. After 15 subjects have been enrolled at the primary site and no serious adverse ...
Detailed Description
With the release of DEFINE-FLAIR and iFR SWEDEHEART, coronary physiology and namely iFR, have robust clinical data supporting its routine use in the cardiac catheterization lab. Unfortunately, iFR is ...
Eligibility Criteria
Inclusion
- Moderate Coronary lesion deemed to need iFR assessment - Angiographic severity of 40-70% that operator feels needs physiologic assessment
- Age 18-90 year old
- Single worst lesion per patient- Patients may have more than one lesion assessed but only 1 lesion will be evaluated per patient in this study
Exclusion
- STEMI- Angiographic severity of 40-70% that operator feels needs physiologic assessment in setting of STEMI or 48hours within STEMI
- Atrial fibrillation
- Inability to provide informed consent- No surrogate or healthcare proxy will be allowed to consent for this study
- Severe tortuosity- Vessel tortuosity that the operator feels would be difficult to pass 2 pressure wires down or where pseudo lesions may be formed.
- Saphenous Vein Graft Lesion
Key Trial Info
Start Date :
August 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04019535
Start Date
August 22 2019
End Date
December 31 2023
Last Update
January 13 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110