Status:
COMPLETED
Automated Algorithm Detecting Physiologic Major Stenosis and Its Relationship With Post-PCI Clinical Outcomes
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Inje University Ilsan Paik Hospital
Keimyung University Dongsan Medical Center
Conditions:
Ischemic Heart Disease
Eligibility:
All Genders
20-85 years
Brief Summary
The presence of myocardial ischemia is the most important prognostic indicator in patients with coronary artery disease. Therefore, the purpose of percutaneous coronary intervention (PCI) is to reliev...
Detailed Description
The current study cohort consisted with 3 cohort. In order to derive and validate the optimal cut-off values of FFR step-up amount for physiologic major vs minor stenosis and for physiologic minor ste...
Eligibility Criteria
Inclusion
- any patient meets eligible criteria who underwent PCI with DES followed by invasive physiologic assessment at the index procedure
- any patient who underwent PCI for lesions with pre-PCI FFR\<=0.80
- available pre-PCI FFR pullback recording
- available both post-PCI FFR measurement
Exclusion
- unavailable pre-PCI FFR pullback recording
- unavailable post-PCI FFR measurement
- culprit vessel of acute coronary syndrome
- failed achieving TIMI 3 flow at the end of PCI
- left ventricular ejection fraction \<30%
- graft vessel
- collateral feeder
- in-stent restenosis
- primary myocardial or valvular heart disease
- in patient whose life expectancy less than 2 years
- visible thrombus of target vessel segment
Key Trial Info
Start Date :
March 22 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
486 Patients enrolled
Trial Details
Trial ID
NCT04304677
Start Date
March 22 2016
End Date
October 1 2022
Last Update
October 26 2022
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea