Status:
COMPLETED
An Evaluation of a Physiology-guided PCI Optimisation Strategy
Lead Sponsor:
NHS National Waiting Times Centre Board
Conditions:
Coronary Artery Disease
Coronary Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
There has recently been renewed interest in the measurement of post percutaneous coronary intervention (PCI) Fractional Flow Reserve (FFR). Previous studies have suggested that post-PCI FFR values ≥0....
Detailed Description
Original hypothesis A simple Physiology-guided Incremental Optimisation Strategy (PIOS) can increase the proportion of patients undergoing PCI in whom a post-PCI FFR ≥0.90 can be achieved from 40% to...
Eligibility Criteria
Inclusion
- Patients \>18 years of age with coronary artery disease (including stable angina and stabilised non-ST-elevation myocardial infarction (NSTEMI)) who are able to provide informed consent.
Exclusion
- PCI in a coronary artery bypass graft
- PCI to an in-stent restenosis (ISR) lesion
- PCI to a target artery providing Rentrop grade 2 or 3 collateral blood supply to another vessel
- Inability to receive adenosine (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker).
- Recent (within 1 week prior to cardiac catheterization) ST-segment elevation myocardial infarction (STEMI) in any arterial distribution (not specifically target lesion).
- Severe cardiomyopathy (ejection fraction \<30%).
- Renal insufficiency such that an additional 20 to 30 mL of contrast would, in the opinion of the operator, pose unwarranted risk to the patient.
Key Trial Info
Start Date :
March 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2020
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT03259815
Start Date
March 8 2018
End Date
December 4 2020
Last Update
March 31 2022
Active Locations (1)
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1
Golden Jubilee National Hospital
Glasgow, United Kingdom, G81 4DY