Clinical trial NCT02812108: Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular Treatment
Official title: Investigation of Clinical and Hemodynamic Factors Affecting the Outcome of Intracranial Aneurysm Embolization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Keywords: intracranial aneurysm
endovascular treatment
recanalization
outcome
hemodynamics
computational fluid dynamic
stent
flow diversion
Lead sponsor: Beijing Neurosurgical Institute
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment

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.

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

Primary outcomes:
measure: hemodynamic factors related to aneurysm recanalization as assessed by computational blood flow simulation
timeFrame: assessed at 6 months (plus or minus 3 months) after procedure
Secondary outcomes:
measure: clinical factors related to aneurysm recanalization as recorded from medical chart
timeFrame: assessed at 6 months (plus or minus 3 months) after procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Study officials:
References:
citation: 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.