The FAVOR V AMI Trial

NCT05669222 | Not Yet Recruiting DMC

• 1 other identifier: FAVOR V AMI
• Study Type: interventional
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

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

Keywords

Quantitative Flow Ratio; ST-Segment Elevation Myocardial Infarction; Multivessel Coronary Artery Disease; Percutaneous Coronary Intervention; Radial Wall Strain

Outcome Measures

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

  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 (11)

• Incidence of cardiovascular death and MI (Major secondary endpoint）

  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)

• Rate of lesion success

  Immediately post the PCI procedure

• Rate of procedural success

  Maximum of 7 days

• Incidence of death

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

• Incidence of all MI

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

Study Arms (2)

FAST Guided Strategy (μQFR+RWS)

EXPERIMENTAL

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.

Diagnostic Test: FAST Technique; Diagnostic Test: Angiography

Standard Treatment Strategy

SHAM COMPARATOR

1. PCI should be performed of all non-culprit lesions with visual DS% ≥70% in all non-infarct related arteries with RVD ≥2.5 mm; 2. For a non-culprit lesion with visually DS% 50-70%, PCI can be performed if FFR ≤0.80 or iFR ≤0.89.

Diagnostic Test: Angiography

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.

Also known as: The next-generation quantitative flow ratio and radial wall strain

FAST Guided Strategy (μQFR+RWS)

Angiography DIAGNOSTIC_TEST

Coronary angiography is a procedure that uses contrast under x-ray pictures to detect stenosis in the coronary arteries.

Also known as: Coronary angiography

FAST Guided Strategy (μQFR+RWS); Standard Treatment Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• No MACE event between the index PCI and the staged randomized procedure
• Able to understand the trial design and provide written informed consent
• 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
• 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.

You may not qualify if:

• 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
• Prior thrombolytic therapy for this admission
• Cockcroft-Gault-calculated CrCl \<30 ml/kg
• Pregnant or woman of child-bearing potential
• Life expectancy less than 1 year for non-cardiac causes
• Allergy to iodine-containing contrast agents which cannot be adequately premedicated
• Unable to tolerate DAPT for at least 6 months
• Prior CABG or planned CABG
• Any planned surgery within 6 months
• Any condition that may interfere with any follow-up procedures (e.g. dementia, drug use)
• 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
• Unable to judge culprit lesion or infarct-related artery according to current evidence

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Related Publications (7)

• Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358.

  PMID: 21247313 BACKGROUND

• Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X.

  PMID: 33714389 BACKGROUND

• Mehta SR, Wood DA, Storey RF, Mehran R, Bainey KR, Nguyen H, Meeks B, Di Pasquale G, Lopez-Sendon J, Faxon DP, Mauri L, Rao SV, Feldman L, Steg PG, Avezum A, Sheth T, Pinilla-Echeverri N, Moreno R, Campo G, Wrigley B, Kedev S, Sutton A, Oliver R, Rodes-Cabau J, Stankovic G, Welsh R, Lavi S, Cantor WJ, Wang J, Nakamya J, Bangdiwala SI, Cairns JA; COMPLETE Trial Steering Committee and Investigators. Complete Revascularization with Multivessel PCI for Myocardial Infarction. N Engl J Med. 2019 Oct 10;381(15):1411-1421. doi: 10.1056/NEJMoa1907775. Epub 2019 Sep 1.

  PMID: 31475795 BACKGROUND

• Puymirat E, Cayla G, Simon T, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, Gallet R, Khalife K, Morelle JF, Motreff P, Lemesle G, Dillinger JG, Lhermusier T, Silvain J, Roule V, Labeque JN, Range G, Ducrocq G, Cottin Y, Blanchard D, Charles Nelson A, De Bruyne B, Chatellier G, Danchin N; FLOWER-MI Study Investigators. Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction. N Engl J Med. 2021 Jul 22;385(4):297-308. doi: 10.1056/NEJMoa2104650. Epub 2021 May 16.

  PMID: 33999545 BACKGROUND

• Xu B, Tu S, Song L, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Yang J, Liu X, Guo L, Shen C, Zhang Y, Zhang Q, Pan H, Fu X, Liu J, Zhao Y, Escaned J, Wang Y, Fearon WF, Dou K, Kirtane AJ, Wu Y, Serruys PW, Yang W, Wijns W, Guan C, Leon MB, Qiao S, Stone GW; FAVOR III China study group. Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China): a multicentre, randomised, sham-controlled trial. Lancet. 2021 Dec 11;398(10317):2149-2159. doi: 10.1016/S0140-6736(21)02248-0. Epub 2021 Nov 4.

  PMID: 34742368 BACKGROUND

• Tu S, Ding D, Chang Y, Li C, Wijns W, Xu B. Diagnostic accuracy of quantitative flow ratio for assessment of coronary stenosis significance from a single angiographic view: A novel method based on bifurcation fractal law. Catheter Cardiovasc Interv. 2021 May 1;97 Suppl 2:1040-1047. doi: 10.1002/ccd.29592. Epub 2021 Mar 4.

  PMID: 33660921 BACKGROUND

• Hong H, Li C, Gutierrez-Chico JL, Wang Z, Huang J, Chu M, Kubo T, Chen L, Wijns W, Tu S. Radial wall strain: a novel angiographic measure of plaque composition and vulnerability. EuroIntervention. 2022 Sep 8;18(12):1001-10. doi: 10.4244/EIJ-D-22-00537. Online ahead of print.

  PMID: 36073027 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Angiography; Coronary Angiography

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Cardiac Imaging Techniques; Heart Function Tests

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Lei Song, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Xu, MBBS

CONTACT

+86-10-88322562; bxu@citmd.com

Lei Song, MD

CONTACT

+86-13241310112; drsong@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2022
• First Posted: December 30, 2022
• Study Start: September 30, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share