Ischemic StrokeNCT01968122
Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China
An observational study of Ischemic Stroke, run by Zhongrong Miao at 1 site in China.
Trial summary
The SAMMPRIS suggested that aggressive treatment was superior to intravascular stenting in patients with severe symptomatic intracranial atherosclerotic stenosis (ICAS) due to high complication rate in patients in stenting group. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- intravascular stent therapy
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Dec 2015
- How long will I take part?
- 1 Year
- 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: Symptomatic ischemic cerebrovascular disease caused by Intracranial atherosclerotic atherosclerosis.Patients with ≥70% stenosis of angiopathic area symptomatic ICAD caused by hypoperfusion combined with poor collateral flow.
Who may be able to join
- 18~80 years old; Primary or recurrent symptomatic intracranial arteriostenosis ineffective through the internal medicine treatment (i.e. stroke or TIA within 90 days during the treatment with at least one anti-thrombotic drugs and vascular risk factor intervention (e.g. hypotensors for hypertension and hypolipidemics for hyperlipidemia);
- 70% stenosis of intracranial responsible angiopathic area under the DSA angiography (as judged through the WASID method);
- 2mm diameter and <15mm length of ill blood vessel, but normal distal blood vessel
- Poor blood circulation in the side branch of responsible angiopathic area under the radiography within one week before the operation:
- Blood flow rate peak of ≥200cm/s at the systolic phase under the transcranial doppler ultrasonic examination (TCD); and Low perfusion in the responsible angiopathic area under the skull perfusion CT (i.e. at a decrease of more than 30% over the perfusion at the opposite side); or <4 scores of blood circulation in the side branch under the DSA; or Hemodynamic ischemic foci under the skull MRI; or Poor blood circulation in the side branch of responsible angiopathic area under the single photon emission computer tomography (SPECT)
Who cannot join
- >50% stenosis beyond the responsible intracranial artery Acute ischemic stroke within 3 weeks Obstruction of bypass branch of ill simple carrier artery under the skull MRI Non-atherosclerotic lesion: MoyaMoya disease, any known vascular inflammatory disease, herpes zoster, angiopathy caused by the chicken-pox, herpes zoster or other viruses, neurosyphilis, other intracranial infections, radioactive angiopathy, maldevelopment of fibrous muscle, sickle-cell anemia, neurofibroma, benign angiopathy of central nervous system, postpartum angiopathy, suspicious vasospasm, and recanalization of suspicious thrombosis Intracranial hemorrhage in the angiopathic area within 6 weeks; Potential source for cardiac embolism Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation >50% stenosis of extracranial carotid or vertebral artery at the same side as intracranial angiopathic area; Known contraindications for heparin, Aspirin, Clopidogrel, anesthetics and contrast medium; hemoglobin <10g/dl, and blood platelet count <100000 Serious neural dysfunction due to the responsible angiopathy as the sequel of cerebral infarction (mRS≥3) International normalization ratio (INR) >1.5 (irreversible), uncorrectable hemorrhagic factor; life expectancy due to the illness <1 year Pregnant/lactating women Inapplicable for intravascular treatment in the viewpoints of investigators
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
Official title: Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China-a Prospective Multicenter Registry Study
The SAMMPRIS suggested that aggressive treatment was superior to intravascular stenting in patients with severe symptomatic intracranial atherosclerotic stenosis (ICAS) due to high complication rate in patients in stenting group. However the intravascular therapy is going on because of low complication rate in considerable Chinese studies coming from several high volume stroke centers. Given to 12.2% patients failing to aggressive medical therap in the SAMMPRIS study, it is imperative to performing an multiple prospective registry study of stenting for patients with ICAS in China.
Read the detailed description
This study is a multicentre prospective single-arm registry study and the protocol is approved by the ethics committee at the coordinating centre and by the local institutional review board at each participating centre. This study is initiated by the investigators, with 20 participating stroke centres (see online supplementary appendix II), and plans to recruit 300 consecutive patients who meet the inclusion and exclusion criteria. After the enrolment, all participants would be evaluated at baseline, day 4, day 30, months 6, months 9 and year 1 (see online supplementary appendix I). The Wingspan stent system is provided by the Boston Scientific company and the Apollo stent is provided by the MicroPort Company, but they will not participate in data collection, analysis, editing or make decisions about the publication. This study is sponsored and conducted by the Cerebrovascular Disease Center of Tiantan Hospital in addition to its responsibility for data analysis. An independent Data and Safety Monitoring Board (DSMB) oversees the conduction, safety and efficacy of the study.
- Conditions
- Ischemic Stroke
- Being tested
- intravascular stent therapy
- Keywords
- symptomatic Intracranial artery stenosis, conventional treatment, stenting, stroke prevention, medical treatment, endovascular treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravascular stent therapyDevice
Also called Gateway balloon plus Wingspan stent system, Apollo stent system
Device selection depended on arterial access and lesion morphology. For patients with smooth arterial access and Mori A lesion or the mid-basilar artery and distal M1 segment lesions, the Apollo balloon-mounted stent was selected. For patients with tortuous arterial access and Mori B or C lesion, or lesion with a significant mismatch in the diameter between proximal and distal segment, angioplasty plus self-expanding stent (Gateway balloon plus Wingspan stent system) is preferred . For patients with tortuous arterial access with a Mori A lesion, or small target vessel diameter (<2.5 mm), direct dilation with Gateway balloon was selected. If severe dissection or elastic recoil occurred after angioplasty, a balloon-mounted stent (for patients with less tortuous access) or Wingspan (for patients with severe tortuous access or small target vessel) stent were allowed to be implanted.
| Study group | Role | What they receive |
|---|---|---|
| aggressive medical treatment | administer Aspirin (100mg/d) + Clopidogrel (75mg/d) for more than 5d before the operation (but Clopidogrel of loading dose 200mg in case of emergency operation for TIA); administer Aspirin (100mg/d) + Clopidogrel (75mg/d) for 90d and subsequent monoclonal antibody after the operation; control the primary risk factors (e.g. hypertension and high LDL); control the secondary risk factors (e.g. diabetes, blood lipid of not high LDL, smoking, obesity and hypomotility); and intervene the life style. Primary risk factors: target systolic pressure of <140mmHg (or <130mmHg in the diabetes patients); and LDL <70mg/dl (1.81mmol/L) or drop by 50%. Receives: Device: intravascular stent therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the target vessel stroke event
Measured: within 30 days after stenting
Secondary outcomes (1)
recurrent ischemic stroke in the involved vascular area
Measured: between 30 days and 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies 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
- 300 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Zhongrong Miao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhongrong Miao, Beijing Tiantan Hospital
- Investigators
- Miao Zh Rong, Doctor, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968122
- Sponsor's protocol ID
- BTH-CRS
- Status last verified
- Apr 2017
- First submitted
- 19 Oct 2013
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gong W, Zhang X, Meng Z, Liu F, Li G, Xiao J, Liu P, Sun Y, Liu T, Wang H, Zhang Y, Wang N. Factors Influencing the Outcome of Symptomatic Intracranial Artery Stenosis With Hemodynamic Impairment After Short and Long-Term Stent Placement. Front Neurol. 2022 May 17;13:682694. doi: 10.3389/fneur.2022.682694. eCollection 2022.
PubMed 35655616Li G, Liu T, Ma X, Gong W, Zhang X, Wang H, Guo Y, Ding Y, Zhang Y. Risk factors associated with recurrence of ischemic stroke after intracranial stenting in china: a case-control study. Neurol Res. 2021 Oct;43(10):802-808. doi: 10.1080/01616412.2021.1937877. Epub 2021 Jun 20.
PubMed 34148505Guo X, Ma N, Gao F, Mo DP, Luo G, Miao ZR. Long-Term Risk Factors for Intracranial In-Stent Restenosis From a Multicenter Trial of Stenting for Symptomatic Intracranial Artery Stenosis Registry in China. Front Neurol. 2021 Jan 26;11:601199. doi: 10.3389/fneur.2020.601199. eCollection 2020.
PubMed 33574792Zhang Y, Sun Y, Li X, Liu T, Liu P, Wang H, Ding J, Miao ZR, Li G. Early versus delayed stenting for intracranial atherosclerotic artery stenosis with ischemic stroke. J Neurointerv Surg. 2020 Mar;12(3):274-278. doi: 10.1136/neurintsurg-2019-015035. Epub 2019 Jul 8.
PubMed 31285375Ma N, Zhang Y, Shuai J, Jiang C, Zhu Q, Chen K, Liu L, Li B, Shi X, Gao L, Liu Y, Wang F, Li Y, Liu T, Zheng H, Mo D, Gao F, Wang Y, Wang Y, Feng L, Miao Z. Stenting for symptomatic intracranial arterial stenosis in China: 1-year outcome of a multicentre registry study. Stroke Vasc Neurol. 2018 May 7;3(3):176-184. doi: 10.1136/svn-2017-000137. eCollection 2018 Sep.
PubMed 30294474Miao Z, Zhang Y, Shuai J, Jiang C, Zhu Q, Chen K, Liu L, Li B, Shi X, Gao L, Liu Y, Wang F, Li Y, Liu T, Zheng H, Wang Y, Wang Y; Study Group of Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China. Thirty-Day Outcome of a Multicenter Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China. Stroke. 2015 Oct;46(10):2822-9. doi: 10.1161/STROKEAHA.115.010549. Epub 2015 Aug 18.
PubMed 26286544Wang Y, Miao Z, Wang Y, Zhao X, Gao P, Liu L, Wang F, Liu Y, Ma N, Xu Z, Mo D, Gao F; China registry study group. Protocol for a prospective, multicentre registry study of stenting for symptomatic intracranial artery stenosis in China. BMJ Open. 2014 Aug 8;4(8):e005175. doi: 10.1136/bmjopen-2014-005175.
PubMed 25107437
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China-a Prospective Multicenter Registry Study
- ClinicalTrials.gov ID
- NCT01968122
- Acronym / sponsor ID
- BTH-CRS
- Conditions
- Ischemic Stroke
- Keywords
- symptomatic Intracranial artery stenosis, conventional treatment, stenting, stroke prevention, medical treatment, endovascular treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Zhongrong MiaoUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Oct 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.
The SAMMPRIS suggested that aggressive treatment was superior to intravascular stenting in patients with severe symptomatic intracranial atherosclerotic stenosis (ICAS) due to high complication rate in patients in stenting group. However the intravascular therapy is going on because of low complication rate in considerable Chinese studies coming from several high volume stroke centers. Given to 12.2% patients failing to aggressive medical therap in the SAMMPRIS study, it is imperative to performing an multiple prospective registry study of stenting for patients with ICAS in China.
Detailed description
This study is a multicentre prospective single-arm registry study and the protocol is approved by the ethics committee at the coordinating centre and by the local institutional review board at each participating centre. This study is initiated by the investigators, with 20 participating stroke centres (see online supplementary appendix II), and plans to recruit 300 consecutive patients who meet the inclusion and exclusion criteria. After the enrolment, all participants would be evaluated at baseline, day 4, day 30, months 6, months 9 and year 1 (see online supplementary appendix I). The Wingspan stent system is provided by the Boston Scientific company and the Apollo stent is provided by the MicroPort Company, but they will not participate in data collection, analysis, editing or make decisions about the publication. This study is sponsored and conducted by the Cerebrovascular Disease Center of Tiantan Hospital in addition to its responsibility for data analysis. An independent Data and Safety Monitoring Board (DSMB) oversees the conduction, safety and efficacy of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aggressive medical treatment | – | Device: intravascular stent therapyadminister Aspirin (100mg/d) + Clopidogrel (75mg/d) for more than 5d before the operation (but Clopidogrel of loading dose 200mg in case of emergency operation for TIA); administer Aspirin (100mg/d) + Clopidogrel (75mg/d) for 90d and subsequent monoclonal antibody after the operation; control the primary risk factors (e.g. hypertension and high LDL); control the secondary risk factors (e.g. diabetes, blood lipid of not high LDL, smoking, obesity and hypomotility); and intervene the life style. Primary risk factors: target systolic pressure of <140mmHg (or <130mmHg in the diabetes patients); and LDL <70mg/dl (1.81mmol/L) or drop by 50%. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic ischemic cerebrovascular disease caused by Intracranial atherosclerotic atherosclerosis.Patients with ≥70% stenosis of angiopathic area symptomatic ICAD caused by hypoperfusion combined with poor collateral flow.
Key inclusion criteria (5 listed)
- 18~80 years old; Primary or recurrent symptomatic intracranial arteriostenosis ineffective through the internal medicine treatment (i.e. stroke or TIA within 90 days during the treatment with at least one anti-thrombotic drugs and vascular risk factor intervention (e.g. hypotensors for hypertension and hypolipidemics for hyperlipidemia);
- 70% stenosis of intracranial responsible angiopathic area under the DSA angiography (as judged through the WASID method);
- 2mm diameter and <15mm length of ill blood vessel, but normal distal blood vessel
- Poor blood circulation in the side branch of responsible angiopathic area under the radiography within one week before the operation:
- Blood flow rate peak of ≥200cm/s at the systolic phase under the transcranial doppler ultrasonic examination (TCD); and Low perfusion in the responsible angiopathic area under the skull perfusion CT (i.e. at a decrease of more than 30% over the perfusion at the opposite side); or <4 scores of blood circulation in the side branch under the DSA; or Hemodynamic ischemic foci under the skull MRI; or Poor blood circulation in the side branch of responsible angiopathic area under the single photon emission computer tomography (SPECT)
Key exclusion criteria (1 listed)
- >50% stenosis beyond the responsible intracranial artery Acute ischemic stroke within 3 weeks Obstruction of bypass branch of ill simple carrier artery under the skull MRI Non-atherosclerotic lesion: MoyaMoya disease, any known vascular inflammatory disease, herpes zoster, angiopathy caused by the chicken-pox, herpes zoster or other viruses, neurosyphilis, other intracranial infections, radioactive angiopathy, maldevelopment of fibrous muscle, sickle-cell anemia, neurofibroma, benign angiopathy of central nervous system, postpartum angiopathy, suspicious vasospasm, and recanalization of suspicious thrombosis Intracranial hemorrhage in the angiopathic area within 6 weeks; Potential source for cardiac embolism Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation >50% stenosis of extracranial carotid or vertebral artery at the same side as intracranial angiopathic area; Known contraindications for heparin, Aspirin, Clopidogrel, anesthetics and contrast medium; hemoglobin <10g/dl, and blood platelet count <100000 Serious neural dysfunction due to the responsible angiopathy as the sequel of cerebral infarction (mRS≥3) International normalization ratio (INR) >1.5 (irreversible), uncorrectable hemorrhagic factor; life expectancy due to the illness <1 year Pregnant/lactating women Inapplicable for intravascular treatment in the viewpoints of investigators
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 |
|---|---|---|
| intravascular stent therapyAlso: Gateway balloon plus Wingspan stent system, Apollo stent systemDevice selection depended on arterial access and lesion morphology. For patients with smooth arterial access and Mori A lesion or the mid-basilar artery and distal M1 segment lesions, the Apollo balloon-mounted stent was selected. For patients with tortuous arterial access and Mori B or C lesion, or lesion with a significant mismatch in the diameter between proximal and distal segment, angioplasty plus self-expanding stent (Gateway balloon plus Wingspan stent system) is preferred . For patients with tortuous arterial access with a Mori A lesion, or small target vessel diameter (<2.5 mm), direct dilation with Gateway balloon was selected. If severe dissection or elastic recoil occurred after angioplasty, a balloon-mounted stent (for patients with less tortuous access) or Wingspan (for patients with severe tortuous access or small target vessel) stent were allowed to be implanted. | Device | aggressive medical treatment |
Primary outcome
the target vessel stroke event
Time frame: within 30 days after stenting
1 secondary outcome
recurrent ischemic stroke in the involved vascular area
Time frame: between 30 days and 1 year postoperatively
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 27 Apr 2017.
- Derived from this study: PubMed 35655616Gong W, Zhang X, Meng Z, Liu F, Li G, Xiao J, Liu P, Sun Y, Liu T, Wang H, Zhang Y, Wang N. Factors Influencing the Outcome of Symptomatic Intracranial Artery Stenosis With Hemodynamic Impairment After Short and Long-Term Stent Placement. Front Neurol. 2022 May 17;13:682694. doi: 10.3389/fneur.2022.682694. eCollection 2022.
- Derived from this study: PubMed 34148505Li G, Liu T, Ma X, Gong W, Zhang X, Wang H, Guo Y, Ding Y, Zhang Y. Risk factors associated with recurrence of ischemic stroke after intracranial stenting in china: a case-control study. Neurol Res. 2021 Oct;43(10):802-808. doi: 10.1080/01616412.2021.1937877. Epub 2021 Jun 20.
- Derived from this study: PubMed 33574792Guo X, Ma N, Gao F, Mo DP, Luo G, Miao ZR. Long-Term Risk Factors for Intracranial In-Stent Restenosis From a Multicenter Trial of Stenting for Symptomatic Intracranial Artery Stenosis Registry in China. Front Neurol. 2021 Jan 26;11:601199. doi: 10.3389/fneur.2020.601199. eCollection 2020.
- Derived from this study: PubMed 31285375Zhang Y, Sun Y, Li X, Liu T, Liu P, Wang H, Ding J, Miao ZR, Li G. Early versus delayed stenting for intracranial atherosclerotic artery stenosis with ischemic stroke. J Neurointerv Surg. 2020 Mar;12(3):274-278. doi: 10.1136/neurintsurg-2019-015035. Epub 2019 Jul 8.
- Derived from this study: PubMed 30294474Ma N, Zhang Y, Shuai J, Jiang C, Zhu Q, Chen K, Liu L, Li B, Shi X, Gao L, Liu Y, Wang F, Li Y, Liu T, Zheng H, Mo D, Gao F, Wang Y, Wang Y, Feng L, Miao Z. Stenting for symptomatic intracranial arterial stenosis in China: 1-year outcome of a multicentre registry study. Stroke Vasc Neurol. 2018 May 7;3(3):176-184. doi: 10.1136/svn-2017-000137. eCollection 2018 Sep.
- Derived from this study: PubMed 26286544Miao Z, Zhang Y, Shuai J, Jiang C, Zhu Q, Chen K, Liu L, Li B, Shi X, Gao L, Liu Y, Wang F, Li Y, Liu T, Zheng H, Wang Y, Wang Y; Study Group of Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China. Thirty-Day Outcome of a Multicenter Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China. Stroke. 2015 Oct;46(10):2822-9. doi: 10.1161/STROKEAHA.115.010549. Epub 2015 Aug 18.
- Derived from this study: PubMed 25107437Wang Y, Miao Z, Wang Y, Zhao X, Gao P, Liu L, Wang F, Liu Y, Ma N, Xu Z, Mo D, Gao F; China registry study group. Protocol for a prospective, multicentre registry study of stenting for symptomatic intracranial artery stenosis in China. BMJ Open. 2014 Aug 8;4(8):e005175. doi: 10.1136/bmjopen-2014-005175.
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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.
Miao Zh Rong, Doctor study chair
Beijing 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 Ischemic Stroke, run by Zhongrong Miao 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 5 inclusion and 1 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 27 Apr 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?
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?
the target vessel stroke event (time frame: within 30 days after stenting). 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 NCT01968122, which also lists 7 linked publications.
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 27 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.