CT-derived FFR-guided invasive treatment versus medical therapy for chronic coronary syndrome.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ACCURATE II is a prospective, randomized, multicenter trial comparing a CT-derived fractional flow reserve (CT-FFR)-guided invasive treatment strategy plus optimal medical therapy to optimal medical therapy alone in patients with chronic coronary syndrome. Eligible adults have chronic coronary syndrome and at least one coronary vessel with CT-FFR ≤ 0.80 and are randomized to either revascularization guided by CT-FFR results or to receive guideline-directed medical therapy. The trial is powered to test whether the CT-FFR-guided strategy is superior for the primary clinical endpoint and includes health economic analyses to compare cost-effectiveness of the two approaches. Key exclusions include prior PCI/CABG, severe heart failure, left main disease, total occlusion, pregnancy, or contraindications to required medications or contrast.

Why it matters

Who can join: the full rules

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

Where it's running

• Second Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Jian'an Wang, MD — Second Affiliated Hospital, Zhejiang University, School of Medicine
• Study coordinator: Jian'an Wang, MD
• Email: wangjianan111@zju.edu.cn
• Phone: +(86)(571) 87784808

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.