Stenting for Symptomatic Intracranial Artery Stenosis Registry in China

Stenting for Symtomatic Intracranial Artery Stenosis Registry in China

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.

Study Overview

• Status: Unknown
• Conditions: Systematic Intracranial Artery Stenosis

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

• Study Contact: Name: yilong Wang, M.D.; Phone Number: 86-13911666571; Email: yilong528@gmail.com

Study Locations

• China
  • Beijing
    • Beiing, Beijing, China, 100050
      • Beijing Tiantan Hospital
      • Contact: Yilong Wang, M.D.; Email: yilong538@gmail.com
      • Sub-Investigator: yilong wang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with systematic Intracranial artery stenosis for stenting procedure

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Stenting; cerebral artery stenting for systematic Intracranial artery stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety during peri-operation period	Stroke in target cerebral vessel or death within 30 days after stenting procedure for systematic Intracranial artery stenosis	30 days after operation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Study Chair: Zhongrong Miao, M.D., Tiantan Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: April 10, 2013
• First Submitted That Met QC Criteria: April 11, 2013
• First Posted (Estimate): April 12, 2013

Study Record Updates

• Last Update Posted (Estimate): April 22, 2013
• Last Update Submitted That Met QC Criteria: April 18, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: stent, systematic Intracranial artery stenosis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: stent-2013