Coronary Artery Disease Clinical Trial
Official title:
Coronary CT Angiography-Derived Fractional Flow Reserve-guided Optimize Treatment Strategy for In-stent Restenosis
This study will be a prospective, randomized clinical trial to compare standard practice guided by usual care testing to CT-FFR-guided management in patients with in-stent restenosis.
This trial will randomize 294 patients with in-stent restenosis to receive either CT-FFR or routine clinical assessment. In all subjects, the investigators will review all diagnostic test results and determine a treatment strategy. The primary end point will be 12-month Major Adverse Coronary Event (MACE) rates, defined as all cause death, non-fatal myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR). Secondary end points will include total medical costs, and quality of life (QOL), medical radiation exposure, etc. We will test noninferiority of current FFR-guided strategy compared with standard care strategy. ;
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