HARET: Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular Treatment

Sponsor

Beijing Neurosurgical Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02812108

Collaborator

(none)

200

Enrollment

Location

7.6

Actual Duration (Months)

26.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysm	Device: intracranial stent, flow diverter and coils

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Mar 20, 2017

Actual Study Completion Date :

Mar 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
HARET All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment	Device: intracranial stent, flow diverter and coils Other Names: Low profile Visualized Intraluminal Device (LVIS); Pipeline™(or Flex) Embolization Device;

Arm

Intervention/Treatment

HARET

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

Device: intracranial stent, flow diverter and coils

Other Names:

Low profile Visualized Intraluminal Device (LVIS);

Pipeline™(or Flex) Embolization Device;

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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