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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
Sponsor:
Information provided by (Responsible Party):
Xinjian Yang, MD, Beijing Neurosurgical Institute

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
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.

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Study Type : Observational
Estimated 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 : August 2016
Actual Primary Completion Date : March 20, 2017
Actual Study Completion Date : March 20, 2017

Resource links provided by the National Library of Medicine


Group/Cohort 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;




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812108


Locations
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China
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Beijing, China, 100050
Sponsors and Collaborators
Beijing Neurosurgical Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xinjian Yang, MD, Vice Chair of Department of Interventional Neuroradiology, Beijing Neurosurgical Institute
ClinicalTrials.gov Identifier: NCT02812108    
Other Study ID Numbers: NSFC-81220108007
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Keywords provided by Xinjian Yang, MD, Beijing Neurosurgical Institute:
intracranial aneurysm
endovascular treatment
recanalization
outcome
hemodynamics
computational fluid dynamic
stent
flow diversion
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases