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The FAVOR V AMI Trial

ConditionsST-Segment Elevation Myocardial InfarctionMultivessel Coronary Artery DiseasePercutaneous Coronary Intervention
Trial statusNot yet recruiting
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

Locations

This trial has no locations.

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

This trial is not recruiting at the moment. You can still explore other options: