Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy

Last updated: April 20, 2023
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chest Pain

Heart Disease

Myocardial Ischemia

Treatment

N/A

Clinical Study ID

NCT05824520
2023-0318
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  • The patient has a known hypersensitivity or contraindication to any of the followingmedications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectivelypre-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

Study Design

Total Participants: 1066
Study Start date:
May 04, 2023
Estimated Completion Date:
May 20, 2026

Study 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.

Connect with a study center

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.