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OPTIMized Diagnosis and Treatment System Based on AI and Multimodal Imaging Fusion for PCI (OPTIMAI-PCI) (OPTIMAI-PCI)

28. September 2026 aktualisiert von: Zhejiang Hospital

An Optimized Diagnosis and Treatment System Based on Artificial Intelligent and Multimodality Imaging Fusion for Percutaneous Coronary Intervention: a Prospective and Multicenter Study

This study compares an AI-based imaging fusion guidance system with standard intravascular ultrasound-guided PCI in adults with complex coronary artery lesions. The system combines angiography and intravascular ultrasound to help physicians plan and optimize stent placement. The study will assess whether the system improves immediate post-procedure vessel function and stent optimization without increasing safety risks.

Studienübersicht

Detaillierte Beschreibung

This prospective, multicenter, randomized, controlled superiority study will enroll adults undergoing PCI for complex non-left-main coronary artery lesions. Participants will be randomized 1:1, stratified by study center, to standard IVUS-guided PCI or PCI assisted by an AI-based imaging fusion guidance system. Both groups will receive standard PCI and peri-procedural care. The primary composite outcome is immediate target-vessel optimization after PCI, defined by post-PCI micro quantitative flow ratio of at least 0.90, minimum stent area of at least 5.0 mm2, and no major stent-edge failure. Clinical follow-up will occur at 1, 6, and 12 months to assess target-vessel failure and safety events.

Studientyp

Interventionell

Einschreibung (Geschätzt)

554

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienkontakt

  • Name: Changqing Du
  • Telefonnummer: +86-13656680012
  • E-Mail: ddcq82@126.com

Studienorte

    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China
        • Zhejiang Hospital
      • Hangzhou, Zhejiang, China
        • Affiliated Hospital of Hangzhou Normal University
      • Hangzhou, Zhejiang, China
        • First Affiliated Hospital, Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China
        • Hangzhou First People's Hospital affiliated with Westlake University School of Medicine
      • Hangzhou, Zhejiang, China
        • Second Affiliated Hospital, Zhejiang University School of Medicine
      • Yuhuan, Zhejiang, China
        • Yuhuan Second People's Hospital
      • Zhoushan, Zhejiang, China
        • Zhoushan Hospital

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

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Age 18 to 80 years, inclusive, at the time of informed consent.
  2. Planned PCI for a target non-left-main coronary lesion meeting at least one of the following: typical myocardial ischemic symptoms with angiographic stenosis >70%; atypical symptoms with angiographic stenosis >=90%; functional measurement by FFR or QFR <0.80; or minimum lumen area below the protocol threshold for vessel diameter (<2.4 mm2 for <3.0 mm, <2.7 mm2 for 3.0-3.5 mm, or <3.6 mm2 for >3.5 mm).
  3. Complex coronary lesion: a single diffuse long lesion >20 mm or tandem lesions separated by >10 mm of non-diseased vessel.
  4. Participant or legally authorized representative can understand and sign written informed consent, can follow study procedures, and agrees to required contraception during the study.

Exclusion Criteria:

  1. Allergy or contraindication to heparin, aspirin, P2Y12 receptor antagonists, or contrast media, except contrast allergy controllable by premedication.
  2. Active pathologic bleeding or gastrointestinal or genitourinary bleeding within 3 months before PCI.
  3. Bleeding tendency or known coagulation disorder, including heparin-induced thrombocytopenia.
  4. Life expectancy <1 year or inability to comply with the protocol, in the investigator's judgment.
  5. Bypass graft lesion, left-main or unprotected left-main coronary lesion.
  6. STEMI within 24 hours of symptom onset or cardiogenic shock at admission (Killip class IV).
  7. Uncontrolled severe systemic disease, including severe hepatic, renal, hematologic, or psychiatric disease; examples include ALT or AST >3 times the upper limit of normal, total bilirubin >1.5 times the upper limit of normal, albumin <35 g/L, cirrhosis or uncontrolled ascites, eGFR <30 mL/min/1.73 m2 or dialysis, platelet count <50 x 10^9/L, hemoglobin <80 g/L, hemolytic anemia, or aplastic anemia.
  8. Pregnant or breastfeeding participant, or plans for pregnancy or breastfeeding during the study.
  9. Target-vessel PCI within 12 months or in-stent restenosis.
  10. Severe calcified lesion or major epicardial coronary ostial lesion expected to require atherectomy pretreatment.
  11. IVUS catheter cannot cross the lesion.
  12. Angiographic image quality inadequate for muQFR analysis, including severe overlap, insufficient projections, or poor contrast filling.

Withdrawal and Exclusion from Per-Protocol Analysis:

  1. PCI not performed after randomization or key imaging missing and not recoverable; participant remains in the intention-to-treat set where applicable.
  2. Withdrawal of informed consent.
  3. Investigator judges continued participation may endanger the participant, such as a serious adverse event or very poor compliance.

Recruitment:

Participants will be screened among inpatients and outpatients scheduled for PCI for complex coronary lesions at participating centers. Investigators will explain the study and obtain written informed consent before enrollment.

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: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Standard IVUS-Guided PCI

Standard percutaneous coronary intervention guided by intravascular ultrasound according to current clinical guidelines, including pre-procedural assessment, stent selection, and post-procedural optimization.

Percutaneous coronary intervention guided by intravascular ultrasound according to current clinical guidelines, including pre-procedural imaging assessment, stent selection, and post-procedural optimization.

Experimental: Imaging Fusion-Guided PCI

Standard percutaneous coronary intervention with use of the AI-based imaging fusion guidance system for ICA-IVUS fusion, virtual stent planning, stent recognition and reconstruction, quantitative assessment of expansion and apposition, and edge-complication alerts.

Percutaneous coronary intervention guided by intravascular ultrasound according to current clinical guidelines, including pre-procedural imaging assessment, stent selection, and post-procedural optimization.

AI-based software device for real-time fusion of coronary angiography and intravascular ultrasound during PCI. It supports virtual stent planning, stent recognition and reconstruction, quantitative evaluation of stent expansion and apposition, detection of edge complications, and functional assessment support including micro quantitative flow ratio.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Immediate Post-PCI Target-Vessel Composite Optimization Success
Zeitfenster: Immediately after PCI (0 hours, before leaving the catheterization laboratory)

Proportion of participants whose target vessel simultaneously meets all three core-laboratory-assessed criteria after final PCI optimization: post-PCI micro quantitative flow ratio (muQFR) >=0.90; minimum stent area (MSA) >=5.0 mm2; and no major stent-edge failure. Major edge failure is defined as longitudinal geographic mismatch (plaque burden >=50% within 5 mm proximal or distal to the stent edge) and/or a major edge dissection involving the media and >3 mm in length.

Immediately after PCI (0 hours, before leaving the catheterization laboratory)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Target Vessel Failure (TVF) through 12 Months
Zeitfenster: 1 month, 6 months, and 12 months after PCI; event-triggered assessment throughout follow-up

Composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization. Suspected events will be adjudicated by the blinded Clinical Events Committee. Stent thrombosis will also be recorded.

1 month, 6 months, and 12 months after PCI; event-triggered assessment throughout follow-up
Peri-Procedural and In-Hospital Safety Events
Zeitfenster: From PCI through hospital discharge or 30 days, whichever occurs first

Incidence of bleeding events, contrast-associated adverse reactions, vascular access-site complications, peri-procedural myocardial infarction or acute vessel closure, serious adverse events, and other clinically significant adverse events during PCI and hospitalization.

From PCI through hospital discharge or 30 days, whichever occurs first
12-Month Safety Outcomes
Zeitfenster: 1 month, 6 months, and 12 months after PCI; event-triggered assessment throughout follow-up

Incidence of serious adverse events, bleeding, stent thrombosis, stroke or systemic embolism, repeat hospitalization, and medication-related adverse reactions during follow-up.

1 month, 6 months, and 12 months after PCI; event-triggered assessment throughout follow-up

Mitarbeiter und Ermittler

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

Ermittler

  • Hauptermittler: Changqing Du, Zhejiang Hospital

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. September 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2027

Studienabschluss (Geschätzt)

1. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

28. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. September 2026

Zuerst gepostet (Tatsächlich)

2. Oktober 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be shared because the data include sensitive personal health information, and the currently approved informed consent and ethics documents do not authorize external sharing of participant-level data.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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