Safety and Effectiveness of Intelligent Microcatheter Shaping Simulation Technology in Coil Embolization of Intracranial Aneurysms: A Prospective, Multicenter, Observational, Real-World Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,438
- 试验地点
- 1
- 主要终点
- Incidence of Major Adverse Events Within 12 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Physician-Experience Microcatheter Shaping (Procedure)
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.
干预措施: AI-Assisted Microcatheter Shaping Simulation Technology (Device)
结局指标
主要结局
Incidence of Major Adverse Events Within 12 Months
时间窗: 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.
Immediate Adequate Occlusion of the Target Aneurysm
时间窗: 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.
次要结局
- Modified Rankin Scale Score(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(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(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(From the index procedure through 12 months after the procedure)
- Incidence of Neurological Events(From the index procedure through 12 months after the procedure)
- Incidence of Target Aneurysm Reintervention or Rehospitalization(From hospital discharge through 12 months after the procedure)
- Length of Index Hospital Stay(At hospital discharge, up to 30 days after admission for the index procedure.)
- Cumulative Treatment-Related Costs(From the index hospitalization through 12 months after the procedure)
- Adequate Occlusion of the Target Aneurysm During Follow-Up(At 180 days (±30 days) and 360 days (±45 days) after the procedure)
- Incidence of Greater Than 50 Percent Parent Artery Stenosis(At 180 days (±30 days) and 360 days (±45 days) after the procedure)
- Microcatheter Delivery Time(During the index coil embolization procedure)
- Number of Microcatheter Delivery Attempts(During the index coil embolization procedure)
- Number of Microcatheter Shaping Attempts(During the index coil embolization procedure)
- Incidence of Microcatheter Instability(During the index coil embolization procedure)
- Incidence of Device-Related Serious Adverse Events(From the index procedure through 12 months after the procedure)