Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China

NCT01968122 | Completed

• 1 other identifier: BTH-CRS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ischemic Stroke

Keywords

symptomatic Intracranial artery stenosis; conventional treatment; stenting; stroke prevention; medical treatment; endovascular treatment

Outcome Measures

Primary Outcomes (1)

• the target vessel stroke event

  within 30 days after stenting

Secondary Outcomes (1)

• recurrent ischemic stroke in the involved vascular area

  between 30 days and 1 year postoperatively

Other Outcomes (1)

• Cognitive function prognosis

  between 30 days and 1 year

Study Arms (1)

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%.

Device: intravascular stent therapy

Interventions

intravascular stent therapy DEVICE

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.

Also known as: Gateway balloon plus Wingspan stent system, Apollo stent system

aggressive medical treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• \~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);
• % stenosis of intracranial responsible angiopathic area under the DSA angiography (as judged through the WASID method);
• mm 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)

You may not qualify if:

• \>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

Sponsors & Collaborators

• Zhongrong Miao: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (7)

• 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.

  PMID: 35655616 DERIVED

• Li 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.

  PMID: 34148505 DERIVED

• Guo 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.

  PMID: 33574792 DERIVED

• Zhang 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.

  PMID: 31285375 DERIVED

• Ma 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.

  PMID: 30294474 DERIVED

• Miao 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.

  PMID: 26286544 DERIVED

• Wang 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.

  PMID: 25107437 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Miao Zh Rong, Doctor

  Beijing Tiantan Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 19, 2013
• First Posted: October 23, 2013
• Study Start: September 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

CN (1)