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The FAVOR V AMI Trial

ConditionsST-Segment Elevation Myocardial InfarctionMultivessel Coronary Artery DiseasePercutaneous Coronary Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

General inclusion

Age ≥18 years

STEMI ≤30d

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)

Disqualifiers

General exclusion

Cardiogenic shock or refractory hypotension (Killip IV)

On pressors or use of or need for intra-aortic balloon pump or other mechanical circulatory support devices

Intubated

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

5,000 Participants
are divided into 2 treatment groups
Group A: FAST Guided Strategy (μQFR+RWS)Experimental treatment 2 interventions
Group B: Standard Treatment StrategySham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of major adverse cardiac events (MACE)

Defined as a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization

Time frame
From the date of first randomization until a total number of 395 events of MACE is reached (median follow-up of approximately 1.5 years)

Secondary outcomes

1

Incidence of cardiovascular death and MI (Major secondary endpoint）

Defined as a composite of cardiovascular death and MI

Time frame
From the date of first randomization until a total number of 395 events of cardiovascular death and MI is reached (median follow-up of approximately 3 years)
2

Rate of lesion success

Defined as: 1) angiographic success (core laboratory-assessed residual stenosis \<30% in stent-treated lesions or \<50% in DCB-treated or PTCA-treated lesions, with TIMI-3 flow in the treated vessel); and 2) physiological success (post-PCI μQFR ≥0.80 assessed by core lab)

Time frame
Immediately post the PCI procedure
3

Rate of procedural success

Defined as lesion success in all treated lesions without in-hospital MACE

Time frame
Maximum of 7 days
4

Incidence of death

Including cardiovascular, non-cardiovascular or undetermined

Time frame
30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China National Center for Cardiovascular Diseases

Lead sponsor

Source ClinicalTrials.gov
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