QFR-Guided Virtual Stenting for Preprocedural Physiological Optimization of Percutaneous Coronary Intervention: A Randomized Controlled Trial (FAVOR-Virtual)
A Multicenter, Prospective, Randomized Controlled Trial of Preprocedural Physiological Optimization of Percutaneous Coronary Intervention Using Coronary Imaging-Physiology Fusion-Based Virtual Stenting Technology
Coronary angiography-guided percutaneous coronary intervention (PCI) remains the standard treatment strategy for patients with coronary artery disease; however, suboptimal post-PCI physiological outcomes remain common and are associated with adverse cardiovascular prognosis. Quantitative Flow Ratio (QFR)-based virtual stenting technology enables simulation of post-intervention coronary physiology before PCI and may facilitate individualized optimization of stent implantation strategies.
This multicenter, prospective, randomized controlled trial aims to evaluate whether preprocedural physiological optimization of PCI using coronary imaging-physiology fusion-based virtual stenting technology improves clinical outcomes compared with conventional angiography-guided PCI. Eligible patients undergoing PCI for coronary artery disease will be randomized in a 1:1 ratio to either virtual stenting-guided PCI optimization or standard angiography-guided PCI.
The primary endpoint is major adverse cardiovascular events (MACE), defined as a composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization within 1 year after PCI. Secondary endpoints include post-PCI physiological optimization, cardiovascular death or nonfatal myocardial infarction, repeat revascularization, quality of life, procedural safety, and health economic outcomes.
Přehled studie
Postavení
Detailní popis
Percutaneous coronary intervention (PCI) guided by coronary angiography remains the current standard treatment approach for coronary artery disease. However, angiographic optimization does not necessarily correspond to physiological optimization, and a considerable proportion of patients experience suboptimal post-PCI coronary physiological results, which are associated with increased risks of adverse cardiovascular events.
Quantitative Flow Ratio (QFR)-derived physiological assessment provides a non-wire, angiography-based method for functional evaluation of coronary lesions. Recent developments in virtual stenting technology enable simulation of residual coronary physiology after hypothetical stent implantation, thereby allowing preprocedural prediction of post-PCI QFR and optimization of interventional strategies.
The present study is a multicenter, prospective, randomized controlled superiority trial designed to evaluate whether coronary imaging-physiology fusion-based virtual stenting technology for preprocedural physiological optimization improves clinical outcomes compared with conventional angiography-guided PCI.
Approximately 1,472 participants with coronary artery disease undergoing PCI will be randomized in a 1:1 ratio to either: Virtual stenting-guided PCI optimization; or Standard angiography-guided PCI.
The primary endpoint is 1-year major adverse cardiovascular events (MACE), defined as a composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization.
Secondary endpoints include immediate post-PCI physiological optimization, cardiovascular death or nonfatal myocardial infarction, repeat revascularization, quality of life assessed by Seattle Angina Questionnaire (SAQ) and EuroQol Five-Dimensional Questionnaire (EQ-5D), procedural safety, and health economic outcomes.
Participants will be followed at 30 days, 6 months, and 12 months after PCI. The study will also evaluate concordance between predicted post-PCI QFR derived from virtual stenting and actual postprocedural physiological measurements, as well as changes in operator treatment strategies after physiological optimization.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Ying Song, MD
- Telefonní číslo: +86-10-68314466
- E-mail: songying@fuwai.com
Studijní místa
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Beijing Municipality
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Beijing, Beijing Municipality, Čína, 100037
- Fuwai Hospital, CAMS & PUMC
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Kontakt:
- Ying Song, MD
- Telefonní číslo: 8688396666
- E-mail: songying@fuwai.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age ≥18 years.
- Diagnosis of coronary artery disease requiring percutaneous coronary intervention (PCI) according to current clinical practice.
- Presence of at least one target coronary lesion considered suitable for PCI and evaluable by angiography-derived Quantitative Flow Ratio (QFR).
- Ability to undergo coronary angiography and PCI. Provision of written informed consent before study participation.
Exclusion Criteria:
- Contraindications to PCI or inability to undergo coronary intervention. Severe renal dysfunction or other conditions making angiographic procedures unsuitable.
- High bleeding risk judged by investigators.
- Inability to complete follow-up or comply with study procedures.
- Life expectancy less than 1 year due to non-cardiovascular comorbidities.
- Participation in another interventional clinical trial that may interfere with study outcomes.
- Coronary anatomy unsuitable for QFR-based virtual stenting analysis.
- Any condition judged by investigators to make study participation inappropriate.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Virtual Stenting-Guided PCI Optimization
Participants randomized to the experimental group will undergo coronary imaging-physiology fusion-based virtual stenting analysis before PCI.
Predicted post-PCI physiological outcomes will be used to optimize interventional strategies, including lesion coverage, stent length, stent position, and procedural planning before stent implantation.
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Preprocedural physiological optimization of PCI using coronary imaging-physiology fusion-based virtual stenting technology based on angiography-derived Quantitative Flow Ratio (QFR) assessment to guide stent implantation strategy.
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Aktivní komparátor: Angiography-Guided PCI
Participants randomized to the control group will undergo PCI according to standard angiographic guidance and operator judgment without virtual stenting-guided physiological optimization.
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Conventional percutaneous coronary intervention performed according to angiographic findings and routine clinical practice without use of virtual stenting-guided physiological optimization.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Major Adverse Cardiovascular Events (MACE)
Časové okno: Within 1 year after PCI
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Composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization after index PCI.
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Within 1 year after PCI
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Post-PCI Physiological Optimization
Časové okno: Immediately after PCI
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Successful physiological optimization defined as postprocedural TIMI grade 3 flow and post-PCI Quantitative Flow Ratio (QFR) ≥0.90 in the target vessel immediately after PCI.
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Immediately after PCI
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Cardiovascular Death or Nonfatal Myocardial Infarction
Časové okno: Within 1 year after PCI
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Composite of cardiovascular death and nonfatal myocardial infarction after index PCI.
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Within 1 year after PCI
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Myocardial Infarction
Časové okno: Within 1 year after PCI
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This includes perioperative myocardial infarction and non-fatal myocardial infarction (including target vessel and non-target vessel related myocardial infarction) (30 days, 6 months, and 1 year postoperatively).
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Within 1 year after PCI
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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All-Cause Mortality
Časové okno: Within 1 year after PCI
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Death from any cause, including cardiovascular death, non-cardiovascular death, or death of undetermined cause.
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Within 1 year after PCI
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Ischemia-Driven Repeat Revascularization
Časové okno: Within 1 year after PCI
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Repeat coronary revascularization (PCI or CABG) associated with ischemic symptoms, positive functional testing, angiographic stenosis ≥50% with ischemic evidence, or stenosis ≥70% regardless of symptoms.
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Within 1 year after PCI
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All revascularization
Časové okno: Within 1 year after PCI
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Including target-vessel and non-target vessel, ischemia-driven and non-ischemia driven
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Within 1 year after PCI
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Definite or Probable Stent Thrombosis
Časové okno: Within 1 year after PCI
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Definite or probable stent thrombosis according to ARC-2 definitions, including acute, subacute, late, and very late stent thrombosis.
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Within 1 year after PCI
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Major Bleeding Events
Časové okno: Within 1 year after PCI
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Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding.
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Within 1 year after PCI
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Health-Related Quality of Life - SAQ
Časové okno: Baseline, 6 months, and 12 months after PCI
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Quality of life assessed using the Seattle Angina Questionnaire (SAQ)
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Baseline, 6 months, and 12 months after PCI
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Health-Related Quality of Life - EQ-5D
Časové okno: Baseline, 6 months, and 12 months after PCI
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Quality of Life assessed by EuroQol Five-Dimensional Questionnaire (EQ-5D).
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Baseline, 6 months, and 12 months after PCI
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Quality-Adjusted Life Years (QALYs)
Časové okno: Within 1 year after PCI
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Cost-utility evaluation using quality-adjusted life years estimated from EQ-5D utility scores using the Japanese time trade-off (TTO) conversion algorithm.
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Within 1 year after PCI
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Healthcare Costs
Časové okno: Baseline, 1 month, 6 months, and 12 months after PCI
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Direct medical costs including index hospitalization costs, cardiovascular medication costs, outpatient costs, hospitalization costs, and MACE-related medical expenditures.
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Baseline, 1 month, 6 months, and 12 months after PCI
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026-2-4036
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