Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular Treatment

Intracranial Aneurysm Clinical Trial

— HARET  

Official title:

Investigation of Clinical and Hemodynamic Factors Affecting the Outcome of Intracranial Aneurysm Embolization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812108
• Other study ID #: NSFC-81220108007
• Status: Completed
• Start date: August 2016
• Est. completion date: March 20, 2017

Study information

• Verified date: January 2021
• Source: Beijing Neurosurgical Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 20, 2017
• Est. primary completion date: March 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• intracranial stent, flow diverter and coils

Locations

Country	Name	City	State
China	Beijing Neurosurgical Institute and Beijing Tiantan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Neurosurgical Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemodynamic factors related to aneurysm recanalization as assessed by computational blood flow simulation	Using computational fluid dynamic method, the parameters as wall shear stress (WSS), flow velocity, pressure could be calculated and analyzed. These will be studied as a composite indicator for recanalization assessment.	assessed at 6 months (plus or minus 3 months) after procedure
Secondary	clinical factors related to aneurysm recanalization as recorded from medical chart	for clinical risk factors as aneurysm size, neck size, treatment method, device use, follow-up interval, smoke history, hypertension, et al, will be recorded and analyzed.These will be studied as a composite indicator for recanalization assessment.	assessed at 6 months (plus or minus 3 months) after procedure