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Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular Treatment

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02812108
Acronym
HARET
Enrollment
200
Registered
2016-06-24
Start date
2016-08-31
Completion date
2017-03-20
Last updated
2021-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Aneurysm

Keywords

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

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 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.

Interventions

Sponsors

Beijing Neurosurgical Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
hemodynamic factors related to aneurysm recanalization as assessed by computational blood flow simulationassessed at 6 months (plus or minus 3 months) after procedureUsing 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

MeasureTime frameDescription
clinical factors related to aneurysm recanalization as recorded from medical chartassessed at 6 months (plus or minus 3 months) after procedurefor 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026