CT-FFR-guided Strategy for In-stent Restenosis
Coronary Artery Disease, In-stent Restenosis

About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary CT Angiography-derived Fractional Flow Reserve, In-stent Restenosis, Major Adverse Coronary Events
Eligibility Criteria
Inclusion Criteria: (1) >18 years old; (2) ability to provide informed consent; (3) previous PCI who underwent CCTA and have at least 1 lesion with a percent diameter in-stent stenosis between 30% and 90% in a coronary artery with a ≥2.25 mm reference vessel diameter by visual assessment; (4) accepted further clinically indicated coronary testing, coronary arteriography, or FFR, or IVUS, or PCI, etc. Exclusion Criteria: (1) Prior coronary artery bypass surgery (CABG), heart valve surgery, cardiac pacemaker, or implanted cardiac defibrillator; (2) Target vascular stents were evaluated for implantation within one month; (3) unstable clinical conditions including acute chest pain, cardiogenic shock, congestive heart failure (NYHA grade III or IV), unstable blood pressure (systolic blood pressure < 90mmHg) or acute pulmonary edema; (4) Acute myocardial infarction occurred within 7 days before enrollment, and left ventricular ejection fraction ≤40%; (5) Other severe cases are not suitable for clinical trials including complex congenital heart disease, sick sinus syndrome, long QT syndrome, severe arrhythmia, tachycardia, severe asthma, severe or very severe chronic obstructive pulmonary disease (COPD) and severe chronic renal damage; (6) Contraindication to beta blockers, nitroglycerin, adenosine, or allergy to iodine contrast agents; (7) Pregnancy or pregnancy status unknown; (8) Life expectancy <1 years; (9)Repeated enrollment; (10) Any other factors that other researchers consider not suitable for inclusion or completion of this study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Other
Experimental
Usual Care
CT-FFR
Participants randomized to usual care will be evaluated according to institutional standard practice. The investigators will review clinical data and results of the diagnostic tests to recommend a treatment strategy, according to the institution's standard practice.
Participants randomized to a CT-FFR strategy will be assigned to non-invasive CT-FFR evaluation. The investigators will review the results CT-FFR, and will recommend a further ICA test if CT-FFR≤0.8. The investigators will review the results of all available diagnostic tests, including CT-FFR and ICA, and will recommend a treatment strategy accordingly.