Overview
The overall purpose of ACCURATE II trial is to compare the clinical outcomes of CT-derived FFR guided strategy versus medical therapy in patients with chronic coronary syndrome.
Description
ACCURATE II is a prospective, multicenter, randomized clinical trial comparing the clinical outcome and cost-effectiveness of the two management strategies. CT-FFR-guided invasive treatment strategy versus optimal medical therapy, in management of patients with chronic coronary syndrome. The study is powered to detect if the primary endpoint by the CT-FFR-guided strategy is superior to the medical therapy strategy.
Eligibility
Inclusion Criteria:
- Age ≥ 18 years, with at least one vessel has CT-derived FFR≤0.80
- Patients with chronic coronary syndromes
- Signed written informed consent
Exclusion Criteria:
- The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled)
- Prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
- Sinus arrhythmia, cardiogenic shock, or severe heart failure (NYHA≥III)
- Inability or unwillingness to undergo CT scan or coronary angiography
- Patients on hemodialysis or with severe hepatic or renal insufficiency
- Left main coronary artery stenosis ≥ 50%
- Target vessel total occlusion
- Pregnancy or intention to become pregnant during the course of the trial
- Patients with a life expectancy less than 2 years
