A single center, prospective, observational study to compare fractional flow reserve (FFR) and intravascular ultrasound (IVUS) percutaneous coronary intervention (PCI) optimization strategies on the functional PCI result (assessed with FFR) immediately post PCI and at 9-12 months after the treatment of long coronary artery lesions.
Study Type
OBSERVATIONAL
Enrollment
154
PCI to long lesion will be optimized according to the IVUS.
PCI to long lesion will be optimized according to the FFR.
Fractional flow reserve protocol will be applied for both FFR-guided and IVUS-guided PCI groups. FFR will be measured according to the standard practice using intravenous adenosine. FFR will be recorded before PCI at the distal third of the coronary artery and after PCI at the same location. In FFR optimization group more than one post PCI FFR measurements could be acquired if the operators performed additional optimization. In IVUS optimization group only one post PCI FFR measurement will be recorded after which the procedure will be considered to be finished, and no further interventions will be undertaken. The same FFR measurements will be performed at 9-12 months follow-up.
The rate of optimal functional PCI result
Post PCI FFR value \< 0.9
Time frame: One year
The rate of poor functional PCI result
Post PCI FFR value ≤ 0.8
Time frame: One year
The rate of optimal anatomical PCI result
If all the four following IVUS criteria met: (1) good stent apposition; (2) good stent expansion (minimal stent area (MSA) \>90% of distal reference lumen area and/or MSA ≥5.5mm2); (3) plaque burden 5mm proximal and distal to the stent \<50%); (4) no stent edge dissection.
Time frame: 1 day
The rate of target vessel failure (TVF)
Composite endpoint (target vessel related death (TV-death), target vessel related myocardial infarction (TV-MI), any target vessel revascularization (TV-R))
Time frame: One year
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