Systematic Intracranial Artery StenosisNCT01830413
Stenting for Symptomatic Intracranial Artery Stenosis Registry in China
An observational study of Systematic Intracranial Artery Stenosis, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Stenting for systematic Intracranial artery stenosis is challenged recently, especially for safety. This registry is aimed to explore the safety profile during peri-operation period in Stenting procedures for systematic Intracranial artery stenosis in Chinese population in real world. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Systematic Intracranial Artery Stenosis
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Dec 2013
- How long will I take part?
- 12 Months
- 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: patients with systematic Intracranial artery stenosis for stenting procedure
Who may be able to join
- 18-80 year old
- medical failure patient with systematic Intracranial artery stenosis
- More than 3 weeks after most recent ischemic stroke
- Digital Subtraction Angiography(DSA) showed ≥70% stenosis in target intracranial artery
- Imaging test within 1 week showed bad collateral circulation in target vessel area
- Diseased vessel diameter≥2mm, length <15mm, distal vessel is normal
Who cannot join
- Diffused intracranial stenosis
- Acute stroke or TIA within 3 weeks
- Pure penetrating branch stenosis showed by cerebral imaging
- Non-atherosclerosis pathology for the stenosis
- Intracranial hemorrhage in target vessel area within 6 weeks; or potential cardiac thrombus source
- Intracranial tumor, arterial aneurysm or intracranial arteriovenous malformation
Show all 11Show fewer
- •>50% stenosis in extracranial carotid artery or vertebral artery in operation side; Known contradiction to heparin, aspirin, clopidogrel, anesthesia or contrast; hemoglobin <10g/dl，platelet count <100000
- Modified Rankin score ≥3 related to target vessel;
- INR(International Normalized Ratio)>1.5(irreversible），persist hemorrhage risk; life expectancy < 1year
- Pregnant or beast-feeding
- Not suitable for endovascular stenting judged by Indication Judgement Committee
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital
Beiing, Beijing Municipality, 100050
Yilong Wang, M.D., yilong538@gmail.com
yilong wang, M.D.
About this study
Official title: Stenting for Symtomatic Intracranial Artery Stenosis Registry in China
Stenting for systematic Intracranial artery stenosis is challenged recently, especially for safety. This registry is aimed to explore the safety profile during peri-operation period in Stenting procedures for systematic Intracranial artery stenosis in Chinese population in real world.
- Conditions
- Systematic Intracranial Artery Stenosis
- Keywords
- stent, systematic Intracranial artery stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stenting | cerebral artery stenting for systematic Intracranial artery stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety during peri-operation period
Stroke in target cerebral vessel or death within 30 days after stenting procedure for systematic Intracranial artery stenosis
Measured: 30 days after operation
Secondary outcomes (15)
Recurrent stroke in 30days to 1 year after stenting in target vessel area.
Recurrent stroke in 30days to 1 year after stenting in target vessel area.
Measured: 30days to 1 year after stenting
Successful recanalization rate right after stenting
Measured: right after stenting
Stent restenosis rate
Measured: Within 1 year after stenting
Ischemic stroke outside target vessel area
Measured: 30 days - 1 year after stenting
Cerebral haemorrhage
Measured: 30 days - 1year after
Myocardial infarction
Measured: within 1 year
non-stroke haemorrhage
Measured: within 1year
Death in 30 days- 1 year after stenting
Measured: 30 days- 1 year after stenting
disabled stroke
Measured: within 1year
Any stroke or death
Measured: within 1 year
Serious adverse event
Measured: within 1year
National Institutes of Health Stroke Scale score(NIHSS score)
Measured: at 30 days and 1 year after stenting
Modified Rankin score(mRS)
Measured: at 30 days and 1 year after stenting
MoCA scale score
Measured: at 30 days and 1 year after stenting
Life quality scale score
Measured: at 1 year after stenting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systematic Intracranial Artery StenosisStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- 450 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongrong Miao, Beijing Tiantan Hospital
- Investigators
- Zhongrong Miao, M.D., Study chair, Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830413
- Sponsor's protocol ID
- stent-2013
- Status last verified
- Apr 2013
- First submitted
- 10 Apr 2013
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stenting for Symtomatic Intracranial Artery Stenosis Registry in China
- ClinicalTrials.gov ID
- NCT01830413
- Acronym / sponsor ID
- stent-2013
- Conditions
- Systematic Intracranial Artery Stenosis
- Keywords
- stent, systematic Intracranial artery stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 Apr 2013 (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.
Stenting for systematic Intracranial artery stenosis is challenged recently, especially for safety. This registry is aimed to explore the safety profile during peri-operation period in Stenting procedures for systematic Intracranial artery stenosis in Chinese population in real world.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stenting | – | –cerebral artery stenting for systematic Intracranial artery stenosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with systematic Intracranial artery stenosis for stenting procedure
Key inclusion criteria (6 listed)
- 18-80 year old
- medical failure patient with systematic Intracranial artery stenosis
- More than 3 weeks after most recent ischemic stroke
- Digital Subtraction Angiography(DSA) showed ≥70% stenosis in target intracranial artery
- Imaging test within 1 week showed bad collateral circulation in target vessel area
Key exclusion criteria (11 listed)
- Diffused intracranial stenosis
- Acute stroke or TIA within 3 weeks
- Pure penetrating branch stenosis showed by cerebral imaging
- Non-atherosclerosis pathology for the stenosis
- Intracranial hemorrhage in target vessel area within 6 weeks; or potential cardiac thrombus source
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety during peri-operation period
Time frame: 30 days after operation
Stroke in target cerebral vessel or death within 30 days after stenting procedure for systematic Intracranial artery stenosis
15 secondary outcomes
Recurrent stroke in 30days to 1 year after stenting in target vessel area.
Time frame: 30days to 1 year after stenting
Successful recanalization rate right after stenting
Time frame: right after stenting
Stent restenosis rate
Time frame: Within 1 year after stenting
Ischemic stroke outside target vessel area
Time frame: 30 days - 1 year after stenting
Cerebral haemorrhage
Time frame: 30 days - 1year after
Myocardial infarction
Time frame: within 1 year
non-stroke haemorrhage
Time frame: within 1year
Death in 30 days- 1 year after stenting
Time frame: 30 days- 1 year after stenting
disabled stroke
Time frame: within 1year
Any stroke or death
Time frame: within 1 year
Serious adverse event
Time frame: within 1year
National Institutes of Health Stroke Scale score(NIHSS score)
Time frame: at 30 days and 1 year after stenting
Modified Rankin score(mRS)
Time frame: at 30 days and 1 year after stenting
MoCA scale score
Time frame: at 30 days and 1 year after stenting
Life quality scale score
Time frame: at 1 year after stenting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
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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.
Zhongrong Miao, M.D. study chair
Tiantan Hospital
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 Systematic Intracranial Artery Stenosis, run by Beijing Tiantan Hospital 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 6 inclusion and 11 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 22 Apr 2013. 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 yilong Wang, M.D. (86-13911666571, yilong528@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety during peri-operation period (time frame: 30 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2013.