Atherosclerotic Intracranial Arterial Stenosis With Intracranial AneurysmsCAIASANCT02795078
The Coexistence of Atherosclerotic Intracranial Arterial Stenosis With Intracranial Aneurysms
An observational study of Atherosclerotic Intracranial Arterial Stenosis With Intracranial Aneurysms, run by liuxingju at 1 site in China.
Trial summary
Atherosclerotic intracranial arterial（ICA） stenosis and intracranial aneurysms are the common causes of ischemic stroke and hemorrhagic stroke, respectively. Investigators aimed to assess the prevalence of cerebral aneurysms in patients with atherosclerotic intracranial arterial stenosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atherosclerotic Intracranial Arterial Stenosis With Intracranial Aneurysms
- What is being tested?
- conservative treatment, Aneurysms clipping and Interventional embolization forAneurysms
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Mar 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient who had the coexistence of intracranial Arterial Stenosis With Intracranial Aneurysms were included in this study
Who may be able to join
- DSA identified the coexistence of intracranial Arterial Stenosis With Intracranial Aneurysms
- Stenosis caused by atherosclerosis
Who cannot join
- patients do not agree
- Stenosis caused by no atherosclerosis disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, 0086
liu xingju, MD, 008615011476305, liuxingju006@163.com
About this study
Official title: To Investigate the Coexistence of Atherosclerotic Intracranial Arterial Stenosis With Intracranial Aneurysms
Atherosclerotic intracranial arterial（ICA） stenosis and intracranial aneurysms are the common causes of ischemic stroke and hemorrhagic stroke, respectively. Investigators aimed to assess the prevalence of cerebral aneurysms in patients with atherosclerotic intracranial arterial stenosis.
Read the detailed description
Based on prospective data of patients with symptomatic or asymptomatic ICA stenosis admitted to Beijing Tiantan Hospital between Jan 2015 and July 2016, all patients underwent brain CTA / MRA/DSA. Investigators determined the number of the patients with intracranial aneurysms, calculated overall prevalence of the coexistence of atherosclerotic ICA stenosis with aneurysms and analyzed the clinical features.
- Being tested
- conservative treatment, Aneurysms clipping, Interventional embolization forAneurysms, stenting for stenosis
- Keywords
- Atherosclerotic Intracranial Arterial Stenosis, Intracranial Aneurysms
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conservative treatmentDrug
Aneurysms clippingProcedure or surgery
Interventional embolization forAneurysmsProcedure or surgery
stenting for stenosisProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
new stroke events during perioperative period
Measured: perioperative period
Secondary outcomes (1)
stroke events during follow up
Measured: 6 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
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 Atherosclerotic Intracranial Arterial Stenosis With Intracranial AneurysmsStudies 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- liuxingju
- Sponsor type
- Other government
- Collaborators
- National Clinical Research Center for Neurological Diseases
- Responsible party
- Sponsor-investigator, liuxingju, Ministry of Science and Technology of the People´s Republic of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795078
- Sponsor's protocol ID
- BJTTH-001
- Acronym
- CAIASA
- Status last verified
- Nov 2017
- First submitted
- 5 Jun 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yin Z, Zhang Q, Zhao Y, Lu J, Ge P, Xie H, Wu D, Yu S, Kang S, Zhang Q, Zhang Y, Zhang D, Zhao J, Liu X. Prevalence and Procedural Risk of Intracranial Atherosclerotic Stenosis Coexisting With Unruptured Intracranial Aneurysm. Stroke. 2023 Jun;54(6):1484-1493. doi: 10.1161/STROKEAHA.122.041553. Epub 2023 May 4.
PubMed 37139814
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Coexistence of Atherosclerotic Intracranial Arterial Stenosis With Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT02795078
- Acronym / sponsor ID
- CAIASA / BJTTH-001
- Keywords
- Atherosclerotic Intracranial Arterial Stenosis, Intracranial Aneurysms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- liuxingjuOther government
- Collaborators
- National Clinical Research Center for Neurological Diseases
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 9 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.
Atherosclerotic intracranial arterial（ICA） stenosis and intracranial aneurysms are the common causes of ischemic stroke and hemorrhagic stroke, respectively. Investigators aimed to assess the prevalence of cerebral aneurysms in patients with atherosclerotic intracranial arterial stenosis.
Detailed description
Based on prospective data of patients with symptomatic or asymptomatic ICA stenosis admitted to Beijing Tiantan Hospital between Jan 2015 and July 2016, all patients underwent brain CTA / MRA/DSA. Investigators determined the number of the patients with intracranial aneurysms, calculated overall prevalence of the coexistence of atherosclerotic ICA stenosis with aneurysms and analyzed the clinical features.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient who had the coexistence of intracranial Arterial Stenosis With Intracranial Aneurysms were included in this study
Key inclusion criteria (2 listed)
- DSA identified the coexistence of intracranial Arterial Stenosis With Intracranial Aneurysms
- Stenosis caused by atherosclerosis
Key exclusion criteria (2 listed)
- patients do not agree
- Stenosis caused by no atherosclerosis disease
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 |
|---|---|---|
| conservative treatment | Drug | – |
| Aneurysms clipping | Procedure or surgery | – |
| Interventional embolization forAneurysms | Procedure or surgery | – |
| stenting for stenosis | Procedure or surgery | – |
Primary outcome
new stroke events during perioperative period
Time frame: perioperative period
1 secondary outcome
stroke events during follow up
Time frame: 6 months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 37139814Yin Z, Zhang Q, Zhao Y, Lu J, Ge P, Xie H, Wu D, Yu S, Kang S, Zhang Q, Zhang Y, Zhang D, Zhao J, Liu X. Prevalence and Procedural Risk of Intracranial Atherosclerotic Stenosis Coexisting With Unruptured Intracranial Aneurysm. Stroke. 2023 Jun;54(6):1484-1493. doi: 10.1161/STROKEAHA.122.041553. Epub 2023 May 4.
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.
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 Atherosclerotic Intracranial Arterial Stenosis With Intracranial Aneurysms, run by liuxingju 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact liu xingju, MD (8615011476305, liuxingju006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
new stroke events during perioperative period (time frame: perioperative period). 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 NCT02795078, 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 6 Nov 2017.