Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular Treatment

Completed

• Conditions: Intracranial Aneurysm
• Interventions: Device: intracranial stent, flow diverter and coils

• Registration Number: NCT02812108
• Lead Sponsor: Beijing Neurosurgical Institute

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.

Study Timeline

• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-24
• Study Start: 2016-08
• Primary Completion: 2017-03-20
• Study Completion: 2017-03-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HARET	intracranial stent, flow diverter and coils	All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment

Primary Outcome Measures

Name	Time	Method
hemodynamic factors related to aneurysm recanalization as assessed by computational blood flow simulation	assessed at 6 months (plus or minus 3 months) after procedure	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.

Secondary Outcome Measures

Name	Time	Method
clinical factors related to aneurysm recanalization as recorded from medical chart	assessed at 6 months (plus or minus 3 months) after procedure	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.

Trial Locations

Locations (1)

Beijing Neurosurgical Institute and Beijing Tiantan Hospital; 🇨🇳 Beijing, China