Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular Treatment

NCT02812108 | Completed

• 1 other identifier: NSFC-81220108007
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Aneurysm

Keywords

intracranial aneurysm; endovascular treatment; recanalization; outcome; hemodynamics; computational fluid dynamic; stent; flow diversion

Outcome Measures

Primary Outcomes (1)

• hemodynamic factors related to aneurysm recanalization as assessed by computational blood flow simulation

  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.

  assessed at 6 months (plus or minus 3 months) after procedure

Secondary Outcomes (1)

• clinical factors related to aneurysm recanalization as recorded from medical chart

  assessed at 6 months (plus or minus 3 months) after procedure

Study Arms (1)

HARET

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

Device: intracranial stent, flow diverter and coils

Interventions

intracranial stent, flow diverter and coils DEVICE

Also known as: Low profile Visualized Intraluminal Device (LVIS);, Pipeline™(or Flex) Embolization Device;

HARET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients treated by endovascular approach for intracranial aneurysm(s)
• Patients older than 18 years
• Patients accepting to participate to the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Neurosurgical Institute: lead

Study Sites (1)

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, 100050, China

Location

Related Publications (1)

• 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.

  PMID: 28501811 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Department of Interventional Neuroradiology

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 24, 2016
• Study Start: August 1, 2016
• Primary Completion: March 20, 2017
• Study Completion: March 20, 2017
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

CN (1)