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QFR-Guided Virtual Stenting for Preprocedural Physiological Optimization of Percutaneous Coronary Intervention: A Randomized Controlled Trial (FAVOR-Virtual)

7. Juni 2026 aktualisiert von: Ying Song, China National Center for Cardiovascular Diseases

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

1472

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100037
        • Fuwai Hospital, CAMS & PUMC
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verfahren: Virtual Stenting-Guided PCI Optimization
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.
Aktiver Komparator: 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.
Verfahren: Standard Angiography-Guided PCI
Conventional percutaneous coronary intervention performed according to angiographic findings and routine clinical practice without use of virtual stenting-guided physiological optimization.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Major Adverse Cardiovascular Events (MACE)
Zeitfenster: Within 1 year after PCI
Composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven repeat revascularization after index PCI.
Within 1 year after PCI

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Post-PCI Physiological Optimization
Zeitfenster: Immediately after PCI
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.
Immediately after PCI
Cardiovascular Death or Nonfatal Myocardial Infarction
Zeitfenster: Within 1 year after PCI
Composite of cardiovascular death and nonfatal myocardial infarction after index PCI.
Within 1 year after PCI
Myocardial Infarction
Zeitfenster: Within 1 year after PCI
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).
Within 1 year after PCI

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
All-Cause Mortality
Zeitfenster: Within 1 year after PCI
Death from any cause, including cardiovascular death, non-cardiovascular death, or death of undetermined cause.
Within 1 year after PCI
Ischemia-Driven Repeat Revascularization
Zeitfenster: Within 1 year after PCI
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.
Within 1 year after PCI
All revascularization
Zeitfenster: Within 1 year after PCI
Including target-vessel and non-target vessel, ischemia-driven and non-ischemia driven
Within 1 year after PCI
Definite or Probable Stent Thrombosis
Zeitfenster: Within 1 year after PCI
Definite or probable stent thrombosis according to ARC-2 definitions, including acute, subacute, late, and very late stent thrombosis.
Within 1 year after PCI
Major Bleeding Events
Zeitfenster: Within 1 year after PCI
Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding.
Within 1 year after PCI
Health-Related Quality of Life - SAQ
Zeitfenster: Baseline, 6 months, and 12 months after PCI
Quality of life assessed using the Seattle Angina Questionnaire (SAQ)
Baseline, 6 months, and 12 months after PCI
Health-Related Quality of Life - EQ-5D
Zeitfenster: Baseline, 6 months, and 12 months after PCI
Quality of Life assessed by EuroQol Five-Dimensional Questionnaire (EQ-5D).
Baseline, 6 months, and 12 months after PCI
Quality-Adjusted Life Years (QALYs)
Zeitfenster: Within 1 year after PCI
Cost-utility evaluation using quality-adjusted life years estimated from EQ-5D utility scores using the Japanese time trade-off (TTO) conversion algorithm.
Within 1 year after PCI
Healthcare Costs
Zeitfenster: Baseline, 1 month, 6 months, and 12 months after PCI
Direct medical costs including index hospitalization costs, cardiovascular medication costs, outpatient costs, hospitalization costs, and MACE-related medical expenditures.
Baseline, 1 month, 6 months, and 12 months after PCI

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

China National Center for Cardiovascular Diseases

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2028

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

1. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juni 2026

Zuerst gepostet (Tatsächlich)

9. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026-2-4036

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Deidentified individual participant data underlying the results reported in publications, including demographic characteristics, baseline clinical variables, procedural information, and outcome measures, may be shared upon reasonable request.

IPD-Sharing-Zeitrahmen

Beginning 12 months after publication and ending 5 years after publication

IPD-Sharing-Zugriffskriterien

Data will be made available to qualified researchers upon reasonable request and approval by the study steering committee, subject to institutional and regulatory requirements.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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