NCT07335029

Brief Summary

This study aims to conduct a comprehensive analysis by integrating clinical factors, aneurysm morphological characteristics, and factors reflecting pathophysiological processes (such as hemodynamic and radiomics features), in order to explore the hemodynamic mechanisms associated with the progression of intracranial dissecting aneurysms. Furthermore, artificial intelligence algorithms will be employed to develop and validate an intelligent risk prediction model for the progression and outcomes of intracranial dissecting aneurysms.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jan 2023Dec 2027

Study Start

First participant enrolled

January 1, 2023

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

January 4, 2026

Last Update Submit

January 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Progression of intracranial dissecting aneurysms

    From enrollment to 12 months of follow-up

Study Arms (2)

Control Group (Non-progression Group)

Imaging progression of intracranial dissecting aneurysms during follow-up

Experimental Group (Progression Group)

Imaging progression of intracranial dissecting aneurysms during follow-up

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The target population consists of patients with intracranial artery dissection (IAD) who received care at the study institution between 2015 and 2025. Eligible participants are adults aged 18-80 years with IAD confirmed by both digital subtraction angiography (DSA) and high-resolution MRI (HR-MRI) according to the imaging diagnostic criteria proposed in the Chinese expert consensus on intracranial artery dissection. Participants are managed with conservative treatment and undergo follow-up, and they provide written informed consent. Key exclusions include arteritis, fibromuscular dysplasia, iatrogenic or traumatic pseudoaneurysm; contraindications to MRI or cerebral angiography (e.g., implanted metallic foreign bodies, claustrophobia, or iodinated contrast allergy); extracranial dissection extending intracranially or concomitant intracranial atherosclerotic plaque in the affected vessel; refusal of MRI; severe comorbidities with an expected survival of less than 2 years; or absence of

You may qualify if:

  • Intracranial dissecting aneurysm clearly diagnosed by DSA and high-resolution MRI imaging (according to the imaging diagnostic criteria proposed in the Chinese Expert Consensus on Imaging Diagnosis of Intracranial Arterial Dissection)
  • patients managed with conservative treatment and follow-up
  • patients who agree and sign a written informed consent form

You may not qualify if:

  • Arteritis, fibromuscular dysplasia, iatrogenic or traumatic pseudoaneurysms
  • Contraindications to MRI examination (such as claustrophobia or metallic implants), or contraindications to cerebral angiography (such as iodine contrast allergy)
  • Dissecting aneurysms extending from the extracranial segment to the intracranial segment, or cases with concomitant intracranial atherosclerotic plaques in the affected vessels
  • Patients who refuse MRI examination
  • Patients with severe comorbid diseases and an expected survival time of less than 2 years due to these conditions
  • Patients without follow-up HR-MRI imaging for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 107000, China

Location

Related Publications (2)

  • Li W, Liu J, Zhang Y, Wang K, Tian Z, Zhang Q, Jiang C, Yang X, Wang Y. Flow Diversion and Outcomes of Vertebral Fusiform Aneurysms After Stent-Only Treatment: A Hemodynamic Study. World Neurosurg. 2017 Nov;107:202-210. doi: 10.1016/j.wneu.2017.07.157. Epub 2017 Aug 4.

  • Zhang Y, Tian Z, Zhu W, Liu J, Wang Y, Wang K, Zhang Y, Yang X, Li W. Endovascular treatment of bilateral intracranial vertebral artery aneurysms: an algorithm based on a 10-year neurointerventional experience. Stroke Vasc Neurol. 2020 Sep;5(3):291-301. doi: 10.1136/svn-2020-000376. Epub 2020 Aug 13.

MeSH Terms

Conditions

Cerebrovascular DisordersIntracranial Aneurysm

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial Arterial DiseasesAneurysm

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 4, 2026

First Posted

January 12, 2026

Study Start

January 1, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

To protect patient privacy, the decision was made not to share the data.

Locations