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Trial record 1 of 1 for:    NCT01830413
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Stenting for Symptomatic Intracranial Artery Stenosis Registry in China

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Zhongrong Miao, Beijing Tiantan Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01830413
First Posted: April 12, 2013
Last Update Posted: April 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhongrong Miao, Beijing Tiantan Hospital
  Purpose
Stenting for systematic Intracranial artery stenosis is challenged recently, especially for safety. This registry is aimed to explore the safety profile during peri-operation period in Stenting procedures for systematic Intracranial artery stenosis in Chinese population in real world.

Condition
Systematic Intracranial Artery Stenosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Stenting for Symtomatic Intracranial Artery Stenosis Registry in China

Further study details as provided by Zhongrong Miao, Beijing Tiantan Hospital:

Primary Outcome Measures:
  • Safety during peri-operation period [ Time Frame: 30 days after operation ]
    Stroke in target cerebral vessel or death within 30 days after stenting procedure for systematic Intracranial artery stenosis


Secondary Outcome Measures:
  • Recurrent stroke in 30days to 1 year after stenting in target vessel area. [ Time Frame: 30days to 1 year after stenting ]
    Recurrent stroke in 30days to 1 year after stenting in target vessel area.

  • Successful recanalization rate right after stenting [ Time Frame: right after stenting ]
  • Stent restenosis rate [ Time Frame: Within 1 year after stenting ]
  • Ischemic stroke outside target vessel area [ Time Frame: 30 days - 1 year after stenting ]
  • Cerebral haemorrhage [ Time Frame: 30 days - 1year after ]
  • Myocardial infarction [ Time Frame: within 1 year ]
  • non-stroke haemorrhage [ Time Frame: within 1year ]
  • Death in 30 days- 1 year after stenting [ Time Frame: 30 days- 1 year after stenting ]
  • disabled stroke [ Time Frame: within 1year ]
  • Any stroke or death [ Time Frame: within 1 year ]
  • Serious adverse event [ Time Frame: within 1year ]
  • National Institutes of Health Stroke Scale score(NIHSS score) [ Time Frame: at 30 days and 1 year after stenting ]
  • Modified Rankin score(mRS) [ Time Frame: at 30 days and 1 year after stenting ]
  • MoCA scale score [ Time Frame: at 30 days and 1 year after stenting ]
  • Life quality scale score [ Time Frame: at 1 year after stenting ]

Estimated Enrollment: 450
Study Start Date: April 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stenting
cerebral artery stenting for systematic Intracranial artery stenosis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with systematic Intracranial artery stenosis for stenting procedure
Criteria

Inclusion Criteria:

  • 18-80 year old
  • medical failure patient with systematic Intracranial artery stenosis
  • More than 3 weeks after most recent ischemic stroke
  • Digital Subtraction Angiography(DSA) showed ≥70% stenosis in target intracranial artery
  • Imaging test within 1 week showed bad collateral circulation in target vessel area
  • Diseased vessel diameter≥2mm, length <15mm, distal vessel is normal

Exclusion Criteria:

  • Diffused intracranial stenosis
  • Acute stroke or TIA within 3 weeks
  • Pure penetrating branch stenosis showed by cerebral imaging
  • Non-atherosclerosis pathology for the stenosis
  • Intracranial hemorrhage in target vessel area within 6 weeks; or potential cardiac thrombus source
  • Intracranial tumor, arterial aneurysm or intracranial arteriovenous malformation

    •>50% stenosis in extracranial carotid artery or vertebral artery in operation side; Known contradiction to heparin, aspirin, clopidogrel, anesthesia or contrast; hemoglobin <10g/dl,platelet count <100000

  • Modified Rankin score ≥3 related to target vessel;
  • INR(International Normalized Ratio)>1.5(irreversible),persist hemorrhage risk; life expectancy < 1year
  • Pregnant or beast-feeding
  • Not suitable for endovascular stenting judged by Indication Judgement Committee
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830413


Contacts
Contact: yilong Wang, M.D. 86-13911666571 yilong528@gmail.com

Locations
China, Beijing
Beijing Tiantan Hospital Not yet recruiting
Beiing, Beijing, China, 100050
Contact: Yilong Wang, M.D.       yilong538@gmail.com   
Sub-Investigator: yilong wang, M.D.         
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
Study Chair: Zhongrong Miao, M.D. Tiantan Hospital
  More Information

Responsible Party: Zhongrong Miao, Doc., Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT01830413     History of Changes
Other Study ID Numbers: stent-2013
First Submitted: April 10, 2013
First Posted: April 12, 2013
Last Update Posted: April 22, 2013
Last Verified: April 2013

Keywords provided by Zhongrong Miao, Beijing Tiantan Hospital:
stent, systematic Intracranial artery stenosis

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical