Intelligent Microcatheter Shaping for Intracranial Aneurysm Coil Embolization
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Hongqi Zhang, M.D
- Numero di telefono: +8613601374152
- Email: xwzhanghq@163.com
Backup dei contatti dello studio
- Nome: Xin Su, M.D
- Numero di telefono: +8618210685023
- Email: 1258940078@qq.com
Luoghi di studio
-
-
-
Beijing, Cina, 100053
- Xuanwu Hospital
-
Contatto:
- Xin Su
- Numero di telefono: +8618210685023
- Email: 1258940078@qq.com
-
Contatto:
- Yongjie Ma, M.D
- Email: mayongjiexuanwu@163.com
-
Sub-investigatore:
- Yongjie Ma, M.D
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Age 18 years or older, with no restriction based on sex.
- 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.
- Ability to understand the study requirements and treatment procedures and provision of written informed consent before any study-specific procedure.
Exclusion Criteria:
- Currently unable or expected to be unable to complete the 1-year follow-up.
- Participation in another clinical study that may affect the results of this study.
- Life expectancy of less than 1 year because of another disease or medical condition.
- Considered unsuitable for participation by the investigator.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
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.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of Major Adverse Events Within 12 Months
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Modified Rankin Scale Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Hongqi Zhang, Xuanwu Hospital, Beijing
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- xwzhqmayongjiesxwsmhyf
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .