Efficacy and Safety of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis

Stroke Clinical Trial

— ESSCAS  

Official title:

Safety and Efficacy of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691314
• Other study ID #: 2006BAI01A10-2
• Status: Completed
• Phase: N/A
• First received: April 12, 2008
• Last updated: February 23, 2011
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Constriction, Pathologic
• Ischemic Attack, Transient
• Stenosis
• Stents
• Stroke
• Transient Ischemic Attack

Intervention

Device:
• Stent implantation (Wingspan, Coroflex, and TiTAN2)
Stent Implantation: Wingspan intracranial stent with Gateway PTA balloon Catheter; Coroflex&reg - balloon expandable stent system and Coroflex Blue - Coronary Stent System; TiTAN2 Bio-active coating stent Standard Medical Management:including antiplatelet agents(Aspirin 75~150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary,interactive education program (Online medical education program, health behavior guide) . Arms: 1

Drug:
• Standard medical treatment
Standard Medical Management:including antiplatelet agents(Aspirin 75~150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary,interactive education program (Online medical education program, health behavior guide)

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing
China	Jilin University	Changchun	Jilin
China	West China Center of Medical Sciences	Chengdu	Sichuan
China	Daping Hospital	Chongqing	Chongqing
China	Southwest Hospital	Chongqing	Chongqing
China	Nanjing General Hospital of Nanjing Military Command	Nanjing	Jiangsu
China	Huashan Hospital Fudan University	Shanghai	Shanghai
China	The General Hospital Under Tianjin Medical Sciences University	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemic stroke in the supply area of stent implantation artery		30 days and 1 year after the procedure	Yes
Secondary	Hemorrhagic stroke		30 days and 1 year after the procedure	Yes
Secondary	Ischemic stroke in the supply area of non-stent implantation artery		30 days and 1 year after the procedure	Yes
Secondary	Acute coronary syndrome		30 days and 1 year after the procedure	Yes
Secondary	All-cause death		30 days and 1 year after the procedure	Yes
Secondary	Transient ischemic attack		30 days and 1 year after the procedure	Yes
Secondary	Degree of re-stenosis of the stent implantation artery		30 days and 1 year after the procedure	Yes