Intracranial AtherosclerosisWingspanSSIRNCT00685308
Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in China
An observational study of Intracranial Atherosclerosis, run by Ministry of Health, China at 1 site in China.
Trial summary
This is a prospective, multi-center, non-randomized trial to study one-year outcomes of the Wingspan system for the treatment of Chinese patients with symptomatic atherosclerotic severe intracranial stenosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracranial Atherosclerosis
- What is being tested?
- Stenting of atherosclerotic intracranial stenosis
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Dec 2007to Oct 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese population with symptomatic severe stenosis of intracranial atherosclerosis
Who may be able to join
- An angiographically verified ≥ 70% stenosis of a major intracranial artery that causes TIA or minor stroke (NIH Stroke Scale score <9) within 90 days;
- the lesion length <15 mm and normal arterial diameter adjacent to it between 2.0 mm and 4.5 mm;
- patients having at least one atherosclerotic risk factor (arterial hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia and cigarette smoking).
Who cannot join
- Non-atherosclerotic stenosis;
- intracranial hemorrhage in the territory of the stenotic artery within 6 weeks; potential source of cardiac embolism;
- concurrent intracranial tumor, aneurysm and cerebral arteriovenous malformation;
- tandem >50% stenosis of extracranial carotid or vertebral artery; known contraindication to heparin, aspirin, clopidogrel, anesthesia and contrast media; hemoglobin <10 g/dl, platelet count <100,000;
- international normalized ratio >1.5 (irreversible) and uncorrectable bleeding diathesis; and life expectancy <1 years because of other medical conditions.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijiang Tiantan Hospital, The Capital Medical University
Beijing, 100050
About this study
This is a prospective, multi-center, non-randomized trial to study one-year outcomes of the Wingspan system for the treatment of Chinese patients with symptomatic atherosclerotic severe intracranial stenosis.
Read the detailed description
The study will enroll 200 Chinese patients with atherosclerotic intracranial stenosis of 70% to 99% that causes a recent ischemic neurologic event.
The Winspan stenting following undersized Gateway balloon angioplasty will be performed at experienced centers (at least 10 cases' experiences of using the Wingspan system to treat the patients with intracranial stenosis for each center).
The primary endpoint of the study, independently evaluated by neurologists, is any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year.
- Conditions
- Intracranial Atherosclerosis
- Being tested
- Stenting of atherosclerotic intracranial stenosis
- Keywords
- Atherosclerosis, Intracranial artery, Angioplasty, Stent
- Medical subject headings
- Intracranial Arteriosclerosis, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stenting of atherosclerotic intracranial stenosisProcedure or surgery
Also called Wingspan stenting for intracranial stenosis
Patients will receive aspirin 300mg and clopidogrel 75mg per day for 3 days or more before stenting,and for at least 1 month after stenting. Modifiable risk factors will be controlled according to major international guidelines.
All stenting procedures will be performed in an elective setting, and under local or general anesthesia. The study will be terminated if stroke or death rate within 30 days of the stenting exceeds 15%.
What is being measured
The primary outcome is the main question the study is designed to answer.
Any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year
Measured: One year
Secondary outcomes (1)
Ischemic stroke in the non-stented artery territory, hemorrhagic stroke and death from other vascular causes beyond 30 days, and emergent cerebral revascularization (ECER)and other major hemorrhages at any time within 1 year, and restenosis.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startDec 2007
- Primary completionOct 2009 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AtherosclerosisStudies 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
- Ministry of Health, China
- Sponsor type
- Other government
- Investigators
- Wei-Jian Jiang, MD, Principal investigator, Beijing Tiantan Hospital, The Capital Medical University, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685308
- Sponsor's protocol ID
- 1122837
- Acronym
- WingspanSSIR
- Status last verified
- May 2008
- First submitted
- 23 May 2008
- Last updated
- 28 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in China
- ClinicalTrials.gov ID
- NCT00685308
- Acronym / sponsor ID
- WingspanSSIR / 1122837
- Conditions
- Intracranial Atherosclerosis
- Keywords
- Atherosclerosis, Intracranial artery, Angioplasty, Stent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ministry of Health, ChinaOther government
- Study start
- Dec 2007
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 28 May 2008 (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 is a prospective, multi-center, non-randomized trial to study one-year outcomes of the Wingspan system for the treatment of Chinese patients with symptomatic atherosclerotic severe intracranial stenosis.
Detailed description
The study will enroll 200 Chinese patients with atherosclerotic intracranial stenosis of 70% to 99% that causes a recent ischemic neurologic event.
The Winspan stenting following undersized Gateway balloon angioplasty will be performed at experienced centers (at least 10 cases' experiences of using the Wingspan system to treat the patients with intracranial stenosis for each center).
The primary endpoint of the study, independently evaluated by neurologists, is any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese population with symptomatic severe stenosis of intracranial atherosclerosis
Key inclusion criteria (3 listed)
- An angiographically verified ≥ 70% stenosis of a major intracranial artery that causes TIA or minor stroke (NIH Stroke Scale score <9) within 90 days;
- the lesion length <15 mm and normal arterial diameter adjacent to it between 2.0 mm and 4.5 mm;
- patients having at least one atherosclerotic risk factor (arterial hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia and cigarette smoking).
Key exclusion criteria (5 listed)
- Non-atherosclerotic stenosis;
- intracranial hemorrhage in the territory of the stenotic artery within 6 weeks; potential source of cardiac embolism;
- concurrent intracranial tumor, aneurysm and cerebral arteriovenous malformation;
- tandem >50% stenosis of extracranial carotid or vertebral artery; known contraindication to heparin, aspirin, clopidogrel, anesthesia and contrast media; hemoglobin <10 g/dl, platelet count <100,000;
- international normalized ratio >1.5 (irreversible) and uncorrectable bleeding diathesis; and life expectancy <1 years because of other medical conditions.
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 |
|---|---|---|
| Stenting of atherosclerotic intracranial stenosisAlso: Wingspan stenting for intracranial stenosisPatients will receive aspirin 300mg and clopidogrel 75mg per day for 3 days or more before stenting,and for at least 1 month after stenting. Modifiable risk factors will be controlled according to major international guidelines. All stenting procedures will be performed in an elective setting, and under local or general anesthesia. The study will be terminated if stroke or death rate within 30 days of the stenting exceeds 15%. | Procedure or surgery | – |
Primary outcome
Any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year
Time frame: One year
1 secondary outcome
Ischemic stroke in the non-stented artery territory, hemorrhagic stroke and death from other vascular causes beyond 30 days, and emergent cerebral revascularization (ECER)and other major hemorrhages at any time within 1 year, and restenosis.
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2008.
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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.
Wei-Jian Jiang, MD principal investigator
Beijing Tiantan Hospital, The Capital Medical University, Beijing, China
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 Atherosclerosis, run by Ministry of Health, China 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 5 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 28 May 2008. 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 Wei-Jian Jiang, MD (86-10-6706-1935, cjr.jiangweijian@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year (time frame: One year). 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 28 May 2008.