RecruitingNot ApplicableNCT05824520

Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy

Coronary Computed Tomography-Derived Fraction Flow Reserve (FFR)-Guided Invasive Treatment Strategy (ITS) Versus Optimal Medical Therapy (OMT) Alone in Patient With Chronic Coronary Syndrome


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

1,066 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria3

  • Age ≥ 18 years, with at least one vessel has CT-derived FFR≤0.80
  • Patients with chronic coronary syndromes
  • Signed written informed consent

Exclusion Criteria9

  • 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

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Interventions

OTHERITS plus OMT

Invasive treatment strategy plus optimal medical therapy

OTHEROMT

Optimal medical therapy alone


Locations(1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT05824520


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