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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
  Purpose

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.


Condition Intervention Phase
Ischemic Cerebrovascular Disease
Device: intravascular stent therapy
Phase 4

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China-a Prospective Multicenter Registry Study

Further study details as provided by Beijing Tiantan Hospital:

Primary Outcome Measures:
  • the target vessel stroke event [ Time Frame: within 30 days after stenting ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • recurrent ischemic stroke in the involved vascular area [ Time Frame: between 30 days and 1 year postoperatively ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Cognitive function prognosis [ Time Frame: between 30 days and 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01968122

Locations
China, Beijing
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Zhongrong Miao
Investigators
Study Chair: Miao Zhong Rong, Doctor Beijing Tiantan Hospital, Capital Medical University
  More Information

No publications provided by Beijing Tiantan Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zhongrong Miao, principal investigator, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT01968122     History of Changes
Other Study ID Numbers: BTH-CRS
Study First Received: October 19, 2013
Last Updated: October 22, 2013
Health Authority: China: Ministry of Health

Keywords provided by Beijing Tiantan Hospital:
symptomatic Intracranial artery stenosis
conventional treatment
stenting
stroke prevention
medical treatment
endovascular treatment

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014