Clinical Trial: Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular Treatment
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Investigation of Clinical and Hemodynamic Factors Affecting the Outcome of Intracranial Aneurysm Embolization
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 Summary:
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.
Sponsor: Beijing Neurosurgical Institute
Current Primary Outcome: 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 ]
Original Primary Outcome: 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 ]
Current Secondary Outcome: clinical factors related to aneurysm recanalization as recorded from medical chart [ Time Frame: assessed at 6 months (plus or minus 3 months) after procedure ]
Original Secondary Outcome: clinical factors related to aneurysm recanalization as recorded from medical chart [ Time Frame: assessed at 6 months (plus or minus 3 months) after procedure ]
Information By: Beijing Neurosurgical Institute
Dates:
Date Received: June 20, 2016
Date Started: August 2016
Date Completion: December 2017
Last Updated: April 27, 2017
Last Verified: April 2017