Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular Treatment (HARET)

January 11, 2021 updated by: Xinjian Yang, MD, Beijing Neurosurgical Institute

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

This study was designed to collect a large series of patients with aneurysms treated endovascularly to analyze hemodynamic factors that affect aneurysm recanalization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100050
        • Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
assessed at 6 months (plus or minus 3 months) after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
assessed at 6 months (plus or minus 3 months) after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Neurosurgical Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

March 20, 2017

Study Completion (Actual)

March 20, 2017

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSFC-81220108007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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