CT-derived FFR-guided invasive treatment versus medical therapy for chronic coronary syndrome.
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
This study will test whether using CT-derived FFR to guide invasive treatment gives better clinical outcomes than optimal medical therapy for adults with chronic coronary syndrome who have at least one vessel with CT-FFR ≤ 0.80.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1066 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05824520 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with chronic coronary syndrome who have at least one coronary vessel with CT-derived FFR ≤ 0.80 and who can undergo CT and coronary angiography and provide informed consent.
Not a fit: Patients with prior PCI or CABG, left main stenosis ≥50%, total vessel occlusion, severe heart failure (NYHA ≥ III), on hemodialysis, or who cannot undergo CT/angiography or require contraindicated medications are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, CT-FFR guidance could help doctors target invasive treatment to patients most likely to benefit, reducing heart-related events and avoiding unnecessary procedures.
How similar studies have performed: Prior observational and diagnostic studies have shown CT-FFR can change care and reduce unneeded invasive angiography, but randomized evidence of improved hard clinical outcomes versus medical therapy is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hangzhou, Zhejiang
- Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Jian'an Wang, MD — Second Affiliated Hospital, School of Medicine, Zhejiang University
- Study coordinator: Jian'an Wang, MD
- Email: wangjianan111@zju.edu.cn
- Phone: +(86)(571) 87784808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.