Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy (ACCURATE II)

Zhejiang University

Status: Enrolling

Conditions: Coronary Artery Disease; Myocardial Ischaemia

Treatments: Other: ITS plus OMT; Other: OMT

Study type: Interventional

Funder types: Other

Identifiers

NCT05824520

2023-0318

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,066 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,066 participants in 2 patient groups

CT-derived FFR guided-ITS group

Experimental group

Description:

CT-derived FFR≤0.8; ITS plus OMT

Treatment:

Other: ITS plus OMT

Medical therapy group

Active Comparator group

Description:

CT-derived FFR≤0.8; OMT alone

Treatment:

Other: OMT