Functional Coronary Angiography Guided Revascularization in STEMI
AIR-STEMI
1 other identifier
interventional
1,823
2 countries
22
Brief Summary
The goal of this multicenter randomized clinical trial is to test the superiority in terms of efficacy of the Angiography-derived fractional flow reserve (AIR) over that based on conventional angiography (ANGIO) strategy in the management of non-culprit lesions in STEMI patients with multivessel disease. The main questions it aims to answer are:
- is an Angiography-derived fractional flow reserve strategy superior to a conventional angiography strategy in reducing the occurrence of the composite efficacy endpoint of all-cause death, myocardial infarction, cerebrovascular accident, or ischemia-driven revascularization.
- is an Angiography-derived fractional flow reserve strategy superior to a conventional angiography strategy in reducing the occurrence of the composite safety endpoint of of contrast-associated acute kidney injury and Bleeding Academic Research Consortium (BARC) type 3-5. Participants will be randomized after the successful treatment of the culprit lesion to one of the two strategies and prospectively followed-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedStudy Start
First participant enrolled
May 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
ExpectedMay 1, 2026
April 1, 2026
2.7 years
March 22, 2023
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Efficacy Outcome: Patient Oriented Composite Outcome
Cumulative occurrence of mortality, cerebrovascular accident, reinfarction, or ischemia-driven revascularization
through study completion, an average of 18 months
Primary Safety Outcome: Major Bleeding and Contrast - Associated Acute Kidney Injury
Cumulative occurrence of contrast-associated acute kidney injury and bleeding BARC 3-5
through study completion, an average of 18 months
Secondary Outcomes (1)
Main Secondary Outcome: Cardiovascular Mortality and Myocardial Infarction
through study completion, an average of 18 months
Study Arms (2)
Angiography-guided PCI
ACTIVE COMPARATORPatients will receive PCI of all lesions with at least 50% diameter stenosis at visual estimation. PCI plan and assessment of PCI results will be based on angiography.
Angiography-derived FFR PCI indication and planning
EXPERIMENTALPatients will receive PCI of all lesions with at least 50% diameter stenosis and positive angiography-derived FFR value (≤0.80). PCI planning will be based on the pullback curve obtained by angiography-derived FFR to obtain an optimal post-PCI physiology.
Interventions
Non-culprit lesion treatment will be based on visual estimation by angiography. The evaluation of PCI result will be also based only on angiography.
Non-culprit lesion treatment will be based on angiography-derived FFR result. In case of positive assessment, PCI will be planned according to the virtual PCI plan based on the physiology pullback curve.
Eligibility Criteria
You may qualify if:
- ST-segment elevation myocardial infarction with indication to invasive management
- Multi-vessel disease defined as at least 1 non-culprit coronary artery lesion at least 2.5 mm in diameter deemed at visual estimation with a diameter stenosis % ranging from 50 to 99% amenable to successful treatment with PCI
- Successful treatment of culprit lesion
You may not qualify if:
- Planned surgical revascularization
- Left main as non-culprit lesion
- Non-cardiovascular co-morbidity reducing life expectancy to \< 1 year
- Any factor precluding 1-year follow-up
- Prior Coronary Artery Bypass Graft (CABG) Surgery
- Impossibility to identify a clear culprit lesion
- Presence of a chronic total occlusion (CTO)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
AUSL Bologna Ospedale Maggiore
Bologna, BO, 40133, Italy
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, FE, 44124, Italy
Ospedale di Bolzano
Bolzano, Italy, 39100, Italy
Azienda Ospedaliero Universitaria Mater Domini
Catanzaro, Italy, Italy
Ospedale Annunziata
Cosenza, Italy, 87100, Italy
Ospedale Civile di Baggiovara
Baggiovara, MO, Italy
AUSL Piacenza
Piacenza, PC, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, PR, Italy
Arcispedale Santa Maria Nuova di Reggio Emilia
Reggio Emilia, RE, 42123, Italy
AUSL Romagna Ospedale degli Infermi Rimini
Rimini, RN, Italy
Ospedale Santa Maria della Misericordia Rovigo
Rovigo, RO, Italy
Ospedale dell'Angelo Mestre
Mestre, VE, 30100, Italy
Ospedale Mater Salutis Legnago
Legnago, VR, Italy
Azienda Ospedaliero Universitaria Integrata di Verona
Verona, VR, Italy
ASST Papa Giovanni XXIII
Bergamo, Italy
AORN Sant'Anna e San Sebastiano
Caserta, Italy
Ospedale Santa Maria Goretti
Latina, Italy
Ospedale Maggiore della Carità Novara
Novara, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
AUSL Romagna Santa Maria delle Croci Ravenna
Ravenna, Italy
Policlinico Casilino
Roma, Italy
NICVD Karachi
Karachi, Pakistan
Related Publications (10)
Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
PMID: 28886621BACKGROUNDMehta SR, Wood DA, Cairns JA. Complete Revascularization with Multivessel PCI for Myocardial Infarction. Reply. N Engl J Med. 2020 Apr 16;382(16):1571-1572. doi: 10.1056/NEJMc2000278. No abstract available.
PMID: 32294360BACKGROUNDPavasini R, Biscaglia S, Barbato E, Tebaldi M, Dudek D, Escaned J, Casella G, Santarelli A, Guiducci V, Gutierrez-Ibanes E, Di Pasquale G, Politi L, Saglietto A, D'Ascenzo F, Campo G. Complete revascularization reduces cardiovascular death in patients with ST-segment elevation myocardial infarction and multivessel disease: systematic review and meta-analysis of randomized clinical trials. Eur Heart J. 2020 Nov 7;41(42):4103-4110. doi: 10.1093/eurheartj/ehz896.
PMID: 31891653BACKGROUNDCollison D, Didagelos M, Aetesam-Ur-Rahman M, Copt S, McDade R, McCartney P, Ford TJ, McClure J, Lindsay M, Shaukat A, Rocchiccioli P, Brogan R, Watkins S, McEntegart M, Good R, Robertson K, O'Boyle P, Davie A, Khan A, Hood S, Eteiba H, Berry C, Oldroyd KG. Post-stenting fractional flow reserve vs coronary angiography for optimization of percutaneous coronary intervention (TARGET-FFR). Eur Heart J. 2021 Dec 1;42(45):4656-4668. doi: 10.1093/eurheartj/ehab449.
PMID: 34279606BACKGROUNDBiscaglia S, Uretsky B, Barbato E, Collet C, Onuma Y, Jeremias A, Tebaldi M, Hakeem A, Kogame N, Sonck J, Escaned J, Serruys PW, Stone GW, Campo G. Invasive Coronary Physiology After Stent Implantation: Another Step Toward Precision Medicine. JACC Cardiovasc Interv. 2021 Feb 8;14(3):237-246. doi: 10.1016/j.jcin.2020.10.055.
PMID: 33541534BACKGROUNDBiscaglia S, Tebaldi M, Brugaletta S, Cerrato E, Erriquez A, Passarini G, Ielasi A, Spitaleri G, Di Girolamo D, Mezzapelle G, Geraci S, Manfrini M, Pavasini R, Barbato E, Campo G. Prognostic Value of QFR Measured Immediately After Successful Stent Implantation: The International Multicenter Prospective HAWKEYE Study. JACC Cardiovasc Interv. 2019 Oct 28;12(20):2079-2088. doi: 10.1016/j.jcin.2019.06.003. Epub 2019 Sep 25.
PMID: 31563688BACKGROUNDRioufol G, Derimay F, Roubille F, Perret T, Motreff P, Angoulvant D, Cottin Y, Meunier L, Cetran L, Cayla G, Harbaoui B, Wiedemann JY, Van Belle E, Pouillot C, Noirclerc N, Morelle JF, Soto FX, Caussin C, Bertrand B, Lefevre T, Dupouy P, Lesault PF, Albert F, Barthelemy O, Koning R, Leborgne L, Barnay P, Chapon P, Armero S, Lafont A, Piot C, Amaz C, Vaz B, Benyahya L, Varillon Y, Ovize M, Mewton N, Finet G; FUTURE Trial Investigators. Fractional Flow Reserve to Guide Treatment of Patients With Multivessel Coronary Artery Disease. J Am Coll Cardiol. 2021 Nov 9;78(19):1875-1885. doi: 10.1016/j.jacc.2021.08.061.
PMID: 34736563BACKGROUNDPuymirat 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: 33999545BACKGROUNDXu 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: 34742368BACKGROUNDErriquez A, Colaiori I, Hakeem A, Guiducci V, Menozzi M, Barbierato M, Arioti M, D'Amario D, Casella G, Scarsini R, Polimeni A, Donazzan L, Benatti G, Venturi G, Ruozzi M, Giordan M, Monello A, Moretti F, Versaci F, Shah JA, Lakho AA, Mantovani F, Cavazza C, Bugani G, Lanzilotti V, Gallo F, Leone AM, Tebaldi M, Pavasini R, Piccolo R, Verardi FM, Farina J, Caglioni S, Cocco M, Campo G, Biscaglia S. Functional coronary angiography to indicate and guide revascularization in STEMI patients with multivessel disease: Rationale and design of the AIR-STEMI trial. Am Heart J. 2025 Jun;284:71-80. doi: 10.1016/j.ahj.2025.02.012. Epub 2025 Feb 19.
PMID: 39984150DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Independent Clinical Event Committee blinded to patient's arm
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
March 22, 2023
First Posted
April 18, 2023
Study Start
May 8, 2023
Primary Completion
January 31, 2026
Study Completion (Estimated)
January 31, 2028
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available for individual patient level analysis in order to merge our data with other trials sharing inclusion and exclusion criteria. Data will be available after the completion of the primary endpoint.
- Access Criteria
- Direct request to study Principal Investigator.
The present study is powered for the patient oriented composite endpoint, but not for CV death and MI. In order to obtain compelling evidence on this latter endpoint, the data of the present study will be merged with those of randomized clinical trials sharing the same inclusion and exclusion criteria, randomization and study interventions.