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Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy

ConditionsCoronary Artery DiseaseMyocardial Ischaemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years, with at least one vessel has CT-derived FFR≤0.80

Patients with chronic coronary syndromes

Signed written informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • ITS plus OMT

    Other intervention

    Invasive treatment strategy plus optimal medical therapy

  • OMT

    Other intervention

    Optimal medical therapy alone

Treatment groups

1,066 Participants
are divided into 2 treatment groups
Group A: CT-derived FFR guided-ITS groupExperimental treatment 1 intervention
Group B: Medical therapy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major adverse cardiac events (MACE)

A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.

Time frame
1 year

Secondary outcomes

1

Death

All-cause death and cardiac death.

Time frame
1 year
2

MI

Target vessel related and non-target vessel related MI.

Time frame
1 year
3

Revascularization

Ischemia driven, non-ischemia driven, target vessel and non-target vessel revascularization.

Time frame
1 year
4

Stroke

Stroke (ischemic and hemorrhagic).

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
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