Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular Treatment (HARET)
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|ClinicalTrials.gov Identifier: NCT02812108|
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : May 11, 2018
|Condition or disease||Intervention/treatment|
|Intracranial Aneurysm||Device: intracranial stent, flow diverter and coils|
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 Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Investigation of Clinical and Hemodynamic Factors Affecting the Outcome of Intracranial Aneurysm Embolization|
|Actual Study Start Date :||August 2016|
|Actual Primary Completion Date :||March 20, 2017|
|Actual Study Completion Date :||March 20, 2017|
All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment
Device: intracranial stent, flow diverter and coils
- hemodynamic factors related to aneurysm recanalization as assessed by computational blood flow simulation [ Time Frame: 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.
- clinical factors related to aneurysm recanalization as recorded from medical chart [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812108
|Beijing Neurosurgical Institute and Beijing Tiantan Hospital|
|Beijing, China, 100050|