Intelligent Microcatheter Shaping for Intracranial Aneurysm Coil Embolization

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.

• Modified Rankin Scale Score [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From the index procedure through 12 months after the procedure]
• Incidence of Neurological Events [Time frame: From the index procedure through 12 months after the procedure]
• Incidence of Target Aneurysm Reintervention or Rehospitalization [Time frame: From hospital discharge through 12 months after the procedure]
• Length of Index Hospital Stay [Time frame: At hospital discharge, up to 30 days after admission for the index procedure.]
• Cumulative Treatment-Related Costs [Time frame: From the index hospitalization through 12 months after the procedure]
• Adequate Occlusion of the Target Aneurysm During Follow-Up [Time frame: At 180 days (±30 days) and 360 days (±45 days) after the procedure]
• Incidence of Greater Than 50 Percent Parent Artery Stenosis [Time frame: At 180 days (±30 days) and 360 days (±45 days) after the procedure]
• Microcatheter Delivery Time [Time frame: During the index coil embolization procedure]
• Number of Microcatheter Delivery Attempts [Time frame: During the index coil embolization procedure]