Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular Treatment

NCT ID: NCT02812108

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-03-20

Brief Summary

This study was designed to collect a large series of patients with aneurysms treated endovascularly to analyze hemodynamic factors that affect aneurysm recanalization.

Detailed Description

With the rapid development of endovascular technique, endovascular treatment has become the first line treatment for intracranial aneurysms (IAs). Compared to microsurgical clipping, less invasive and lower morbidity have been shown after endovascular treatment. However, the aneurysms recanalization is the drawback of such modality. It has been reported that many factors, including complete initial embolization, stent assisted coiling, dense packing and flow diverter, could reduce recanalization rate. Larger size, wide neck, rupture status and intraluminal thrombosis are reported as risk factors of aneurysm recanalization. However, no analysis of hemodynamic risk factors affecting the aneurysm recanalization has been conducted in a large prospective series of patients.

Hemodynamics is reported to play an important role in aneurysm initiation, growth and rupture. Previous studies have showed that the hemodynamics is associated with outcomes of aneurysms after endovascular treatment. High wall shear stress and flow velocity are risk factors of aneurysm recanalization. However, the relationship between hemodynamics and aneurysm outcomes is still unclear. To explore the hemodynamic predictors of aneurysm recanalization is of great value for clinical practice.

Hemodynamic analysis for intracranial aneurysms recanalization after endovascular treatment (HARET) is a prospective trial designed to collect a large series of patients with aneurysms treated endovascularly to analyze hemodynamic factors that affect aneurysm recanalization.

Conditions

Intracranial Aneurysm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HARET

All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment

intracranial stent, flow diverter and coils

Intervention Type: DEVICE

Interventions

intracranial stent, flow diverter and coils

Intervention Type: DEVICE

Other Intervention Names

Low profile Visualized Intraluminal Device (LVIS); Pipeline™(or Flex) Embolization Device;

Eligibility Criteria

Inclusion Criteria

• Patients treated by endovascular approach for intracranial aneurysm(s)
• Patients older than 18 years
• Patients accepting to participate to the study

Exclusion Criteria

• Patients already treated by endovascular approach for an intracranial aneurysm
• Patients having a brain arteriovenous malformation
• Patients having a fusiform aneurysm
• Patients having a dissecting aneurysm
• Patients treated by parent vessel occlusion
• Patients treated by covered stent
• Patients lacking 3-dimensional aneurysm images or the images not satisfied the simulation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Neurosurgical Institute

OTHER

Sponsor Role: lead

Responsible Party

Xinjian Yang, MD

Vice Chair of Department of Interventional Neuroradiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, , China

Countries

China

References

Liu J, Zhang Y, Wang A, Zhang Y, Li Y, Yang X. Haemodynamic analysis for recanalisation of intracranial aneurysms after endovascular treatment: an observational registry study in China. BMJ Open. 2017 May 12;7(5):e014261. doi: 10.1136/bmjopen-2016-014261.

Reference Type: DERIVED

PMID: 28501811 (View on PubMed)

Other Identifiers

NSFC-81220108007

Identifier Type: -

Identifier Source: org_study_id