Clinical trial NCT00691314: Efficacy and Safety of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis
Official title: Safety and Efficacy of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Transient Ischemic Attack
Atherosclerosis
Stenosis
Stents
Keywords: Stroke
Transietn Ischemic Attack
Stents
Stenosis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2008-06-05
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy and safety of stent implantation in patients with symptomatic extra- and intracranial artery stenosis and to determine its role in secondary prevention of ischemic stroke.


Eligibility criteria: Inclusion Criteria:

1. Aged between above 40 year-old and 75 year-old.
2. Ischemic stroke related to extra- and intracranial atherosclerosis stenosis, transient ischemic attack (TIA ), onset time within 90 days
3. Implantation of stent should be at least 1 week after stroke onset, and patient's medical condition stable, no time limit for TIA,
4. Stenosed ICA or MCA or BA or VA is the candidate arteries for stent implantation.
5. Degree of stenosis of target artery ranges between 51%-99%
6. Modified Rankin score≤3 or NIHSS Score ≤4
7. Informed consent is obtained.

Exclusion Criteria:

Patients will be excluded from entry if any of the criteria listed below are met:

1. Target stenosis artery is not suitable for stent implantation after evaluation.
2. Previous carotid endarterectomy or carotid artery stent ,or intracranial artery stent implantation.
3. Ischemic stroke is caused by conditions other than atherosclerosis .
4. Documented non-atherosclerosis angiopathy.
5. Clinically unstable at the time of enrollment,
6. Conditions which may lead to cardiogenic embolism : arterial fibrillation，left ventricular thrombi,Myocardiac infarction within 6 weeks,etc.
7. Severe hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg)
8. Severe co-morbid or unstable medical condition, ie，severe heart failure, pulmonary failure or renal failure, liver dysfunction (serum liver enzyme twice or more than normal level),malignancy with likelihood of death within the next 2 years
9. Significant memory or behavioral disorder, ie, Alzheimer disease, etc.daily care needed.
10. Concurrent participation in another clinical trial
11. Unable to return follow up
12. History of hemorrhagic disease(ie, intracranial hemorrhage, Idiopathic Thrombocytopenic Purpura,etc ) or bleeding tendency conditions.
13. Intracranial arteriovenous malformation or aneurysm.

Primary outcomes:
measure: Ischemic stroke in the supply area of stent implantation artery
timeFrame: 30 days and 1 year after the procedure
Secondary outcomes:
measure: Hemorrhagic stroke
timeFrame: 30 days and 1 year after the procedure
measure: Ischemic stroke in the supply area of non-stent implantation artery
timeFrame: 30 days and 1 year after the procedure
measure: Acute coronary syndrome
timeFrame: 30 days and 1 year after the procedure
measure: All-cause death
timeFrame: 30 days and 1 year after the procedure
measure: Transient ischemic attack
timeFrame: 30 days and 1 year after the procedure
measure: Degree of re-stenosis of the stent implantation artery
timeFrame: 30 days and 1 year after the procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
city: Chongqing
country: China
facility: Daping Hospital
state: Chongqing
city: Nanjing
country: China
facility: Nanjing General Hospital of Nanjing Military Command
state: Jiangsu
city: Changchun
country: China
facility: Jilin University
state: Jilin
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Center of Medical Sciences
state: Sichuan
city: Tianjin
country: China
facility: The General Hospital Under Tianjin Medical Sciences University
state: Tianjin
Study officials:
affiliation: Peking Union Medical College Hospital
name: Liying Cui
role: PRINCIPAL_INVESTIGATOR
References: