Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular Treatment (HARET)

Beijing Neurosurgical Institute

Status: Completed

Conditions: Intracranial Aneurysm

Treatments: Device: intracranial stent, flow diverter and coils

Study type: Observational

Funder types: Other

Identifiers

NCT02812108

NSFC-81220108007

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

HARET

Description:

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

Treatment:

Device: intracranial stent, flow diverter and coils