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The FAVOR V AMI Trial

Sponsor: China National Center for Cardiovascular Diseases • ClinicalTrials.gov ID: NCT05669222

Registry updated: 2026-09-24
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Description

The FAVOR V AMI study is a prospective, multicenter, blinded, randomized, sham-controlled trial comparing the long-term clinical outcomes of the "Functional and Angiography-derived Strain inTegration (FAST)" technique (next-generation quantitative flow ratio \[μQFR\] and radial wall strain \[RWS\]) guided percutaneous coronary intervention (PCI) strategy, with standard treatment strategy, in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary disease (MVD).

Interventions

  • FAST Technique (Diagnostic test)
    The next-generation QFR (μQFR) introduces a more intelligent algorithm and supports single-projection rapid calculation with a diagnostic accuracy of 93.0% compared with FFR; Computational RWS technique facilitates the assessment of lesion vulnerability.
  • Angiography (Diagnostic test)
    Coronary angiography is a procedure that uses contrast under x-ray pictures to detect stenosis in the coronary arteries.

Eligibility criteria

Inclusion Criteria: * General inclusion 1. Age ≥18 years 2. STEMI ≤30d 3. Successful primary PCI of all culprit lesion(s) responsible for the STEMI (visually-assessed residual stenosis \<30% in stent-treated lesions or \<50% in DCB-treated or PTCA-treated lesions, with TIMI-3 flow in all treated vessels) 4. No MACE event between the index PCI and the staged randomized procedure 5. Able to understand the trial design and provide written informed consent * Angiographic inclusion: 1. The presence of at least 1 non-culprit lesion with DS% 50%-90% in any non-infarct related artery with RVD ≥2.5 mm by visual assessment 2. Non-culprit lesions are potentially eligible for PCI Note: All lesions in the infarct related arteries with DS ≥70% and RVD ≥2.5 mm by visual assessment must be successfully treated either during the index primary PCI or the staged procedure prior to randomization Note: There may also be 1 or more NCL with DS% \>90% (including a CTO) as long as there is at least 1 NCL with DS% 50%-90% as above. Any such lesions in which PCI is intended must be treated successfully either during the index primary PCI or the staged procedure prior to randomization. Exclusion Criteria: * General exclusion 1. Cardiogenic shock or refractory hypotension (Killip IV) 2. On pressors or use of or need for intra-aortic balloon pump or other mechanical circulatory support devices 3. Intubated 4. Prior thrombolytic therapy for this admission 5. Cockcroft-Gault-calculated CrCl \<30 ml/kg 6. Pregnant or woman of child-bearing potential 7. Life expectancy less than 1 year for non-cardiac causes 8. Allergy to iodine-containing contrast agents which cannot be adequately premedicated 9. Unable to tolerate DAPT for at least 6 months 10. Prior CABG or planned CABG 11. Any planned surgery within 6 months 12. Any condition that may interfere with any follow-up procedures (e.g. dementia, drug use) * Angiographic exclusion 1. Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification, branch ostium cannot be shown clearly, severe overlap in the stenosed segment or severe tortuosity of any interrogated vessel deemed not amenable to μQFR or RWS measurement 2. Unable to judge culprit lesion or infarct-related artery according to current evidence

Conditions

ST-Segment Elevation Myocardial Infarction Multivessel Coronary Artery Disease Percutaneous Coronary Intervention

Locations

  • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing — Beijing, Beijing Municipality, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record