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Intelligent Microcatheter Shaping for Intracranial Aneurysm Coil Embolization

2. August 2026 aktualisiert von: Xuanwu Hospital, Beijing

Safety and Effectiveness of Intelligent Microcatheter Shaping Simulation Technology in Coil Embolization of Intracranial Aneurysms: A Prospective, Multicenter, Observational, Real-World Registry Study

This prospective, multicenter, observational registry study will evaluate the real-world safety, effectiveness, and clinical value of artificial intelligence (AI)-assisted microcatheter shaping during coil embolization of intracranial aneurysms.

Adults with an intracranial aneurysm who are scheduled to undergo coil embolization will be enrolled and followed for approximately 12 months. The study will not assign participants to a treatment strategy. All treatment decisions will be made by the treating physicians according to routine clinical practice.

Participants will be analyzed according to whether microcatheter shaping is performed based on the physician's experience alone or with assistance from an intelligent microcatheter shaping simulation technology. The study will evaluate major adverse events within 12 months, immediate aneurysm occlusion after the procedure, clinical and quality-of-life outcomes, follow-up imaging findings, serious adverse events, repeat treatment or rehospitalization, microcatheter delivery performance, and health care resource use. At least 1,438 participants are planned to be enrolled.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Microcatheter shaping is an important technical step in the endovascular coil embolization of intracranial aneurysms. The shape and stability of the microcatheter may affect access to the aneurysm, coil delivery, procedural efficiency, and procedural safety. The AI-assisted microcatheter shaping simulation technology evaluated in this study analyzes three-dimensional cerebrovascular anatomy to assist with aneurysm localization and measurement and to generate a suggested microcatheter shaping plan. The technology provides decision support, while the treating physician remains responsible for all clinical decisions.

This is a prospective, multicenter, observational, real-world registry study. Adult patients with an intracranial aneurysm confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography and scheduled to undergo coil embolization may be enrolled after providing written informed consent. Participants will not be randomly assigned to a treatment group, and participation in the registry will not determine the treatment received.

For analysis, participants will be classified into two observational cohorts according to actual clinical practice. In the physician-experience cohort, microcatheter shaping is performed according to the treating physician's experience. In the AI-assisted cohort, microcatheter shaping is performed with support from the intelligent microcatheter shaping simulation technology.

Study information will be collected during six planned visits: screening, the procedure, the postoperative hospitalization period, approximately 30 days after treatment, approximately 180 days after treatment, and approximately 360 days after treatment. Collected data will include participant characteristics, medical history, aneurysm and parent-artery morphology, procedural and device information, medication use, microcatheter delivery time and attempts, number of shaping attempts, microcatheter stability, clinical outcomes, quality of life, imaging outcomes, adverse events, serious adverse events, repeat interventions, rehospitalizations, and health care resource use.

The primary safety evaluation is the occurrence of major adverse events within 12 months, defined as neurological death or major ischemic or hemorrhagic stroke. Major stroke is defined as an increase of at least 4 points on the National Institutes of Health Stroke Scale. The primary effectiveness evaluation is immediate adequate aneurysm occlusion after coil embolization, defined as Raymond grade I or II.

Because the use of AI-assisted technology is determined by routine clinical practice rather than random assignment, statistical analyses will focus on estimating differences between the two cohorts while accounting for potential confounding factors. Regression-based adjustment will be used, with propensity score methods and sensitivity analyses considered when appropriate.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

1438

Kontakte und Standorte

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

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

The study population will include adults with an intracranial aneurysm confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography who are scheduled to undergo coil embolization at participating study centers. Eligible patients will be enrolled prospectively after providing written informed consent. Participants will be classified into the physician-experience cohort or the AI-assisted cohort according to whether intelligent microcatheter shaping simulation technology is used during routine clinical care. Treatment strategy and use of the technology will not be assigned by the study protocol.

Beschreibung

Inclusion Criteria:

  1. Age 18 years or older, with no restriction based on sex.
  2. Diagnosis of an intracranial aneurysm confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography, with the target aneurysm planned for treatment by coil embolization.
  3. Ability to understand the study requirements and treatment procedures and provision of written informed consent before any study-specific procedure.

Exclusion Criteria:

  1. Currently unable or expected to be unable to complete the 1-year follow-up.
  2. Participation in another clinical study that may affect the results of this study.
  3. Life expectancy of less than 1 year because of another disease or medical condition.
  4. Considered unsuitable for participation by the investigator.

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Physician-Experience Cohort
Participants undergoing coil embolization of an intracranial aneurysm in whom microcatheter shaping is performed according to the treating physician's experience, without assistance from the intelligent microcatheter shaping simulation technology.
Verfahren: Physician-Experience Microcatheter Shaping
Microcatheter shaping is planned and performed by the treating physician according to clinical experience without assistance from the intelligent microcatheter shaping simulation technology. The shaping approach is determined during routine clinical care and is not assigned by the study protocol.
AI-Assisted Cohort
Participants undergoing coil embolization of an intracranial aneurysm in whom microcatheter shaping is performed with assistance from the intelligent microcatheter shaping simulation technology.
Gerät: AI-Assisted Microcatheter Shaping Simulation Technology
An artificial intelligence-based decision-support technology that analyzes three-dimensional cerebrovascular anatomy, assists with aneurysm localization and measurement, and provides a suggested microcatheter shaping plan for intracranial aneurysm coil embolization. Use of the technology is determined by routine clinical practice and is not assigned by the study protocol.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Major Adverse Events Within 12 Months
Zeitfenster: From the index procedure through 12 months after the procedure
Percentage of participants who experience at least one major adverse event from the index coil embolization procedure through 12 months. A major adverse event is defined as neurological death or major ischemic or hemorrhagic stroke. Major stroke is defined as an increase of at least 4 points on the National Institutes of Health Stroke Scale.
From the index procedure through 12 months after the procedure
Immediate Adequate Occlusion of the Target Aneurysm
Zeitfenster: Immediately after coil embolization on the day of the procedure
Percentage of participants whose treated target aneurysm is classified as Raymond grade I or II on angiographic assessment immediately after coil embolization.
Immediately after coil embolization on the day of the procedure

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Modified Rankin Scale Score
Zeitfenster: At hospital discharge or Day 7 after the procedure, 30 days (±15 days), 180 days (±30 days), and 360 days (±45 days) after the procedure
Distribution of modified Rankin Scale scores. The scale ranges from 0 to 6, with 0 indicating no symptoms and 6 indicating death. Lower scores indicate better functional status.
At hospital discharge or Day 7 after the procedure, 30 days (±15 days), 180 days (±30 days), and 360 days (±45 days) after the procedure
EQ-5D-5L Health Utility Index
Zeitfenster: At baseline, hospital discharge or Day 7 after the procedure, 30 days (±15 days), 180 days (±30 days), and 360 days (±45 days) after the procedure
Health-related quality of life assessed using the EQ-5D-5L questionnaire, which evaluates mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Responses will be converted to a health utility index according to the prespecified scoring method.
At baseline, hospital discharge or Day 7 after the procedure, 30 days (±15 days), 180 days (±30 days), and 360 days (±45 days) after the procedure
EQ Visual Analog Scale Score
Zeitfenster: At baseline, hospital discharge or Day 7 after the procedure, 30 days (±15 days), 180 days (±30 days), and 360 days (±45 days) after the procedure
Participant-reported overall health status measured using the EQ Visual Analog Scale. Scores range from 0 to 100, with higher scores indicating better self-reported health.
At baseline, hospital discharge or Day 7 after the procedure, 30 days (±15 days), 180 days (±30 days), and 360 days (±45 days) after the procedure
Incidence of Procedure-Related Serious Adverse Events
Zeitfenster: From the index procedure through 12 months after the procedure
Percentage of participants who experience at least one serious adverse event considered by the investigator to be related to the coil embolization procedure.
From the index procedure through 12 months after the procedure
Incidence of Neurological Events
Zeitfenster: From the index procedure through 12 months after the procedure
Percentage of participants who experience at least one neurological event, including ischemic stroke, hemorrhagic stroke, neurological death, intracranial hemorrhage, subarachnoid hemorrhage, arterial thrombosis, perforation or rupture of the parent artery or a branch artery, or transient ischemic attack.
From the index procedure through 12 months after the procedure
Incidence of Target Aneurysm Reintervention or Rehospitalization
Zeitfenster: From hospital discharge through 12 months after the procedure
Percentage of participants who undergo repeat treatment of the target aneurysm or are rehospitalized after the index coil embolization procedure.
From hospital discharge through 12 months after the procedure
Length of Index Hospital Stay
Zeitfenster: At hospital discharge, up to 30 days after admission for the index procedure.
Number of days from admission for the index coil embolization procedure to hospital discharge.
At hospital discharge, up to 30 days after admission for the index procedure.
Cumulative Treatment-Related Costs
Zeitfenster: From the index hospitalization through 12 months after the procedure
Cumulative treatment-related costs in Chinese yuan, including costs of the index hospitalization, diagnostic examinations, surgical treatment, medical devices and consumables, medications, follow-up examinations, treatment of complications, direct nonmedical costs, and recorded indirect costs.
From the index hospitalization through 12 months after the procedure
Adequate Occlusion of the Target Aneurysm During Follow-Up
Zeitfenster: At 180 days (±30 days) and 360 days (±45 days) after the procedure
Percentage of participants whose treated target aneurysm is classified as Raymond grade I or II on follow-up vascular imaging.
At 180 days (±30 days) and 360 days (±45 days) after the procedure
Incidence of Greater Than 50 Percent Parent Artery Stenosis
Zeitfenster: At 180 days (±30 days) and 360 days (±45 days) after the procedure
Percentage of participants with greater than 50 percent stenosis of the parent artery at the location of the treated target aneurysm on follow-up vascular imaging.
At 180 days (±30 days) and 360 days (±45 days) after the procedure
Microcatheter Delivery Time
Zeitfenster: During the index coil embolization procedure
Time required to deliver the microcatheter to the intended position for coil embolization, recorded in hours, minutes, and seconds.
During the index coil embolization procedure
Number of Microcatheter Delivery Attempts
Zeitfenster: During the index coil embolization procedure
Number of attempts required to deliver the microcatheter to the intended position, categorized as 1, 2, 3, or more than 3 attempts.
During the index coil embolization procedure
Number of Microcatheter Shaping Attempts
Zeitfenster: During the index coil embolization procedure
Number of microcatheter shaping attempts required during the procedure, categorized as 1, 2, 3, or more than 3 attempts.
During the index coil embolization procedure
Incidence of Microcatheter Instability
Zeitfenster: During the index coil embolization procedure
Percentage of participants in whom microcatheter kickback or displacement occurs during coil embolization. Microcatheter instability is recorded as a binary outcome of yes or no.
During the index coil embolization procedure
Incidence of Device-Related Serious Adverse Events
Zeitfenster: From the index procedure through 12 months after the procedure
Percentage of participants who experience at least one serious adverse event considered by the investigator to be related to a device used during the coil embolization procedure, including the intelligent microcatheter shaping simulation technology when applicable.
From the index procedure through 12 months after the procedure

Mitarbeiter und Ermittler

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

Sponsor

Xuanwu Hospital, Beijing

Mitarbeiter

Peking University First Hospital
Beijing Tiantan Hospital
Chinese PLA General Hospital
Peking University Third Hospital
Qilu Hospital of Shandong University
Peking University International Hospital
Shandong Provincial Hospital
Beijing Chao Yang Hospital
Beijing Hospital
Qingdao Municipal Hospital
Beijing Anzhen Hospital
First Hospital of China Medical University
Beijing Haidian Hospital
Tengzhou Central People's Hospital
Panjin Liaoyou Gem Flower Hospital
Beijing Tsinghua Changgeng Hospital
Linyi People's Hospital
Civil Aviation General Hospital
Seventh Medical Center of PLA Army General Hospital
Aerospace Center Hospital
Central Hospital Affiliated to Shenyang Medical Collage
Affiliated Zhongshan Hospital of Dalian University
Union Strong（Beijing）Technology Co.Ltd.
The Second Qilu Hospital of Shandong University
The General Hospital of the PLA Northern Theater Command
Shenyang Sujiatun District Central Hospital
Northeast International Hospital

Ermittler

  • Hauptermittler: Hongqi Zhang, Xuanwu Hospital, Beijing

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

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. August 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2029

Studienabschluss (Geschätzt)

1. Dezember 2029

Studienanmeldedaten

Zuerst eingereicht

28. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. August 2026

Zuerst gepostet (Tatsächlich)

6. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • xwzhqmayongjiesxwsmhyf

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be publicly shared because the study involves multicenter clinical and imaging data containing potentially sensitive health information. The data will be used only for the purposes specified in the study protocol and will be managed in accordance with participant consent, institutional policies, ethics committee requirements, and applicable data protection regulations. De-identified aggregate results may be reported in scientific publications.

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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