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NCT Number: NCT06539767

Risk Assessment and Mechanism Analysis of Intracranial Multiple Aneurysm Instability Based on High-resolution Magnetic Resonance, Imaging Histology and Hemodynamics

This project proposes to establish a prospective cohort of MIA based on a preexisting multicenter MIA database and to combine multidimensional methods such as high-resolution magnetic resonance, hemodynamics, ambulatory blood pressure, and imaging histology to study aneurysm instability.

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Key information

Conditions

Arterial Aneurysm Wall Enhancement on HRMRI

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhujiang Hospital, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80 years old, male or infertile female;
  • Diagnosed as IA (intracranial aneurysm) through CTA, MRA, or DSA; And it is suitable for endovascular intervention treatment
  • The patient and/or their legal representative or guardian fully understand the research purpose, voluntarily participate and sign informed consent Books;
  • Patients willing to cooperate with high-resolution magnetic resonance imaging.
  • Patients willing to follow up and evaluate according to clinical research protocol requirements

Exclusion criteria

  • AVM (arteriovenous malformation), Moyamoya disease, or DAVF (dural arteriovenous fistula) related aneurysms;
  • Patients with contraindications for high-resolution magnetic resonance imaging;
  • Participants in clinical trials of other drugs or medical devices;
  • Patients with severe underlying diseases and extremely poor clinical conditions who cannot tolerate general anesthesia surgery;
  • Patients with poor compliance and inability to cooperate with follow-up;
  • Possible or clear history of severe allergy to contrast agents;
  • Patients with a life expectancy of less than 2 years;
  • Women who are breastfeeding and preparing for pregnancy during the study period

Treatment and study plan

Primary outcomes

  1. High resolution MRI aneurysm features

    Time frame: 1 year

    Enhancement grade was defined as follows: grade 0 for none enhancement, grade 1 for focal enhancement, involved the neck, the intermediate portion, the dome, or a bleb;grade 2 for thin annular enhancement (maximum thickness≤1 mm) , grade 3 for thick annular enhancement(maximum thickness>1 mm) .

Secondary outcomes

  1. postoperative mRS score

    Time frame: 1 year

    MRS score definition: The MRS score, also known as the Modified Rankin Scale, is a scale used to evaluate the neurological recovery status of stroke patients. It is divided into seven levels, Level 0: completely asymptomatic. Level 1: Despite symptoms, without obvious disabilities, able to complete all frequently engaged work and activities.

    Level 2: Mild disability, unable to complete all work and activities, but able to handle personal affairs without the need for assistance from others.

    Level 3: Moderate disability, requiring assistance from others to walking without assistance.

    Level 4: Severe disability, unable to walk without the help of others, unable to take care of one's own needs.

    Level 5: Severe disability, bedridden, urinary and fecal incontinence, requiring continuous care, and requiring multiple 24-hour care from others.

    Level 6: Death. The higher the mRS score, the worse the patient's prognosis.

  2. postoperative aneurysm occlusion rate

    Time frame: 1 year

    Raymond classification, grade I: complete embolism; Grade II: residual aneurysm neck;

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2024
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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