The FAVOR V AMI Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2028-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fast Radial Pharmaco-invasive Strategy In ST Elevation Myocardial Infarction Trial

NCT04300582

ST-segment Elevation Myocardial Infarction (STEMI)

UNKNOWN NA

Compare Early With Deferred Invasive Strategy for STEMI Presenting 24-48 Hours From Symptom Onset

NCT04575012

ST-segment Elevation Myocardial Infarction (STEMI)

NOT_YET_RECRUITING NA

FFR Versus Angiography-Guided Strategy for Management of AMI With Multivessel Disease

NCT02715518

Acute Myocardial Infarction

COMPLETED NA

Evaluate Early Invasive Strategy for Patients With STEMI Presenting 24-48 Hours From Symptom Onset

NCT04962178

ST-segment Elevation Myocardial Infarction (STEMI)

UNKNOWN NA

MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction -The MULTISTARS AMI Trial

NCT03135275

ST-elevation Myocardial Infarction Multivessel Coronary Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The FAVOR V AMI study is a prospective, multicenter, blinded, randomized, sham-controlled trial comparing the long-term clinical outcome of the two PCI strategies, the FAST guided strategy (test group) versus standard treatment strategy (control group), in a high-risk population with STEMI and MVD who underwent successful primary PCI of the infarct-related artery. The primary endpoint is major adverse cardiac events (MACE), defined as a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization when the last patient reaches 6-month follow-up. The major secondary endpoint is cardiovascular death and MI when at least 395 total events have accrued. The study hypothesis is the FAST (μQFR+RWS) guided PCI strategy is superior to a standard treatment strategy by the primary and major secondary endpoint.

For the patients randomized to μQFR+RWS group, μQFR will be measured in all non-infarct related arteries containing any non-culprit lesion with visually-assessed percentage diameter stenosis (DS%) ≥50% and ≤90% with reference vessel diameter (RVD) ≥2.5 mm. If μQFR ≤0.80 or RWS ≥13%, PCI will be performed; if μQFR \>0.80 and RWS \<13%, the procedure will deferral; if DS% \>90%, PCI should be performed without the need of μQFR or RWS. For all patients undergoing PCI, post-PCI μQFR measurement is recommended; if μQFR \<0.90, if the reason is obvious post-dilation with a non-compliant balloon or bail-out stenting should be considered; if the reason is not obvious intravascular imaging should be considered. For the patients randomized to standard treatment group, PCI should be performed of all non-culprit lesions with visual DS% ≥70% in all non-infarct related arteries with RVD ≥2.5 mm; for a non-culprit lesion with visually DS% 50-70%, PCI can be performed if fractional flow reserve (FFR) ≤0.80 or instantaneous wave-free ratio (iFR) ≤0.89. All patients will be followed by either telephone or clinic visit at 1 month, 6 months,1 year, 2 years, 3 years, 4 years and 5 years.

The sample size will be about 5,000 using an event-driven sample calculation. An adaptive design will be implemented for sample size re-estimation when 90% of patients have been enrolled. All principal analyses will take place in the intention-to-treat (ITT) population. The primary and major secondary endpoints will be analyzed in prespecified subgroups, including age (≥65 vs. \<65), sex (men vs. women), diabetes (yes vs. no), time from symptom onset to primary PCI (≤ vs. \> median), planned number of NCLs for PCI in the control arm (0/1 vs. 2 vs. 3), infarct related artery (LM/LAD vs, others), untreated CTOs with RVD ≥2.5 mm in non-infarct related artery (yes vs. no), timing of elective PCI (same hospitalization as the emergency PCI vs. during an elective readmission), P2Y12 inhibitor therapy (Clopidogrel vs. Ticagrelor), treatment of any non-infarct lesion with DS \>90% prior to randomization (yes vs. no), LVEF (echo post primary PCI, prior to randomization) (\>40% vs. ≤40%), Killip Class (I vs. ≥II), lesion location of non-culprit lesion (LM/LAD vs. others), diseased vessels (two-vessel disease vs. LM/three-vessel disease), moderate or severe calcification in any NCL (yes vs. no), bifurcation lesion with planned main vessel and SB treatment in any NCL (yes vs. no), intravascular guidance during the randomized procedure (yes vs. no), μQFR grayzone (μQFR \< 0.75 vs. = 0.75-0.85 vs. \> 0.85 \[by core laboratory\]), μQFR-based functional SYNTAX score (FSSQFR, low tertile vs. mid tertile vs. high tertile \[by core laboratory\]), post-PCI μQFR (≥0.90 vs. \<0.90 \[by core laboratory\]), angiography-derived IMR (≥2.5 mmHgs/cm vs. \<2.5 mmHgs/cm \[by core laboratory\]), residual physiology pattern (PPG diffuse vs. local \[by core laboratory\]), μQFR-based residual functional SYNTAX score (rFSSQFR, 0 vs. ≥ 1 \[by core laboratory\]), learning experience of μQFR/RWS (first half vs. second half of enrolled cases in each center).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

This is a blinded clinical trial. Subjects and clinical assessor (including the follow-up research personnel, clinical events committee (CEC) members, and angiographic core laboratory analysts) will be blinded to the assignment results. All the study site personnel will receive training for the blinding measures before the trial initiating. In addition to standard procedural sedation, music-playing headphones will be worn by the patient during the whole procedure, and patients in both groups will be preset a 10-minute delay for μQFR+RWS or sham calculation before the PCI procedure, a lesion/device evaluation form is required to fill in during the period in both groups, to reduce the possibility of unblinding. All the study site personnel will be trained not to disclose the treatment assignment to the subject in any unplanned time. Blinding to the subjects will maintain until 5-year follow-up completed.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FAST Guided Strategy (μQFR+RWS)

1. μQFR is measured in all non-infarct related arteries containing any non-culprit lesion with visually-assessed DS% ≥50% and ≤90% with RVD ≥2.5 mm.

1. μQFR ≤0.80: PCI
2. RWS ≥13%: PCI
3. μQFR \>0.80 and RWS \<13%: Deferral
4. DS% \>90%: PCI without the need of μQFR or RWS
2. For all patients undergoing PCI, post-PCI μQFR measurement is recommended; if μQFR \<0.90, if the reason is obvious post-dilation with a non-compliant balloon or bail-out stenting should be considered; if the reason is not obvious intravascular imaging should be considered.

Group Type EXPERIMENTAL