Intracranial AneurysmHARETNCT02812108
Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular Treatment
An observational study of Intracranial Aneurysm, run by Beijing Neurosurgical Institute at 1 site in China.
Trial summary
This study was designed to collect a large series of patients with aneurysms treated endovascularly to analyze hemodynamic factors that affect aneurysm recanalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- intracranial stent, flow diverter and coils
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to 20 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment
Who may be able to join
- Patients treated by endovascular approach for intracranial aneurysm(s)
- Patients older than 18 years
- Patients accepting to participate to the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Beijing, 100050
About this study
Official title: 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.
Read the 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.
- Conditions
- Intracranial Aneurysm
- Being tested
- intracranial stent, flow diverter and coils
- Keywords
- intracranial aneurysm, endovascular treatment, recanalization, outcome, hemodynamics, computational fluid dynamic, stent, flow diversion
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracranial stent, flow diverter and coilsDevice
Also called Low profile Visualized Intraluminal Device (LVIS);, Pipeline™(or Flex) Embolization Device;
| Study group | Role | What they receive |
|---|---|---|
| HARET | All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment Receives: Device: intracranial stent, flow diverter and coils |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: assessed at 6 months (plus or minus 3 months) after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startAug 2016
- Primary completion20 Mar 2017
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Neurosurgical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinjian Yang, MD, Beijing Neurosurgical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812108
- Sponsor's protocol ID
- NSFC-81220108007
- Acronym
- HARET
- Status last verified
- Jan 2021
- First submitted
- 20 Jun 2016
- Last updated
- 13 Jan 2021
- Results posted
- No
Publications
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.
PubMed 28501811
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Clinical and Hemodynamic Factors Affecting the Outcome of Intracranial Aneurysm Embolization
- ClinicalTrials.gov ID
- NCT02812108
- Acronym / sponsor ID
- HARET / NSFC-81220108007
- Conditions
- Intracranial Aneurysm
- Keywords
- intracranial aneurysm, endovascular treatment, recanalization, outcome, hemodynamics, computational fluid dynamic, stent, flow diversion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Neurosurgical InstituteUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HARET | – | Device: intracranial stent, flow diverter and coilsAll patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment
Key inclusion criteria (3 listed)
- Patients treated by endovascular approach for intracranial aneurysm(s)
- Patients older than 18 years
- Patients accepting to participate to the study
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intracranial stent, flow diverter and coilsAlso: Low profile Visualized Intraluminal Device (LVIS);, Pipeline™(or Flex) Embolization Device; | Device | HARET |
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
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.
1 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Derived from this study: PubMed 28501811Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Beijing Neurosurgical Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02812108, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.