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Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Zhongrong Miao, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier:
NCT01968122
First received: October 19, 2013
Last updated: October 22, 2013
Last verified: October 2013

October 19, 2013
October 22, 2013
September 2013
October 2014   (final data collection date for primary outcome measure)
the target vessel stroke event [ Time Frame: within 30 days after stenting ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01968122 on ClinicalTrials.gov Archive Site
recurrent ischemic stroke in the involved vascular area [ Time Frame: between 30 days and 1 year postoperatively ] [ Designated as safety issue: Yes ]
Same as current
Cognitive function prognosis [ Time Frame: between 30 days and 1 year ] [ Designated as safety issue: No ]
Same as current
 
Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China
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.

Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
1 Year
Not Provided
Probability Sample

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.

Ischemic Cerebrovascular Disease
Device: intravascular stent therapy
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.
Other Names:
  • Gateway balloon plus Wingspan stent system
  • Apollo stent system
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%.
Intervention: Device: intravascular stent therapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
January 2015
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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)

Exclusion Criteria:

  • >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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01968122
BTH-CRS
No
Zhongrong Miao, Beijing Tiantan Hospital
Zhongrong Miao
Not Provided
Study Chair: Miao Zhong Rong, Doctor Beijing Tiantan Hospital, Capital Medical University
Beijing Tiantan Hospital
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP