FAST-guided PCI in STEMI with Multivessel Disease

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

FAVOR V AMI is a multicenter, blinded, randomized, sham-controlled study in STEMI patients with multivessel disease who have had successful primary PCI. It compares a FAST-guided PCI strategy using μQFR and radial wall strain to the standard treatment approach, with major adverse cardiac events as the primary endpoint at 6 months. The trial analyzes non-culprit lesions in eligible patients and applies predefined μQFR and RWS criteria to decide whether to treat or defer non-culprit lesions. Post-PCI μQFR measurements may guide further optimization. The study aims to determine if the FAST-guided approach improves long-term cardiovascular outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Bo Xu, MBBS — Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing; Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, Shenzhen
• Study coordinator: Bo Xu, MBBS
• Email: bxu@citmd.com
• Phone: +86-10-88322562

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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.