carotid stenosis
Conditions
Interventions
A:normal saline 100 ml i.v. 1 week before operation
B:Tozumab 160 mg i.v. 1 week before operation
C:Tozumab 320 mg i.v. 1 week before operation
D:Adalimumab 80 mg i.v. 1 week before operation
E:Adalimumab 160 mg i.v. 1 week before operation
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Clinical Inclusion Criteria 1. Age =18 years old; 2. Symptomatic status: Symptomatic patient, as evidenced by transient ischemic attack (TIA), amaurosis fugax, minor or non-disabling stroke (in thehemisphere supplied by the target vessel), within 180 days of the randomization date. This study will not include asymptomatic patients; 3. hs-CRP= 2 mg/L; 4. No childbearing potential or has a negative pregnancy test within one week prior to study procedure; 5. Patient and patient's physician agree to have the patient return for all required clinical contacts; 6. Written informed consent. Anatomic Inclusion Criteria 1. Discrete lesion located in the internal carotid artery (ICA) (with or without involvement of the contiguous common carotid artery (CCA)). 2. Degree of Stenosis: Symptomatic patients with carotid stenosis = 70% defined as: ? Stenosis =70% by ultrasound ? Stenosis =70% by angiography (based on NASCET Criteria) or ? If the ultrasound indicates 50-69% stenosis, that patient may be randomized on the basis of results from a CT angiogram (CTA) or MR angiogram (MRA) IF a radiologist or neuro-imaging specialist documents his/her opinion that a CTA or MRA indicate = 70% stenosis and that the CTA or MRA is of acceptable technical quality. If the results of the CTA or MRA are not conclusive, the patient should undergo conventional angiography. 3. Target ICA vessel reference diameter must be measured to be =4.0 mm and =9.0 mm. Target ICA measurements may be made from angiography of the contralateral artery. 4. In the presence of bilateral stenosis treatment of the non-study artery must take place at least 30 days prior to randomization, or >30 days after the study procedure is completed. 5. Expected ability to deliver the stent to the lesion.
Exclusion criteria
Exclusion criteria: 1. Evolving stroke. 2. Untoward reaction to anesthesia not able to be overcome by pretreatment with medications. 3. Intolerance or allergic reaction to any of the study medications, including aspirin (ASA), ticlopidine and clopidogrel. 4. Active bleeding diathesis or coagulopathy or will refuse blood transfusions. 5. Prior major ipsilateral stroke if likely to confound study endpoints. 6. Severe dementia. 7. Spontaneous intracranial hemorrhage within the past 12 months. 8. Recent (1.5, bleeding time >1 minute beyond upper limit normal, or heparinassociated thrombocytopenia. 11. Any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe. 12. Neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke. 13. Actively participating in another drug or device trial that has not completed the required protocol follow-up period. 14. Inability to understand and cooperate with study procedures or provide informed consent. 15. Chronic atrial fibrillation. 16. Other cardiac sources of emboli such as left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma. 17. Active tuberculosis, Hepatitis B, Hepatitis C or AIDS. 18. Any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation. 19. MI within previous 30 days. 20. Recent GI bleed that would interfere with antiplatelet therapy. 21. Long-term immunosuppressive therapy. 22. Non-surgical or a high risk surgical candidate defined as the presence of any one of the following: 1) Knowledge of two or more proximal or major diseased coronary arteries with =70% stenosis that have not, or cannot be revascularized; 2) Ejection fraction 400 mg/dl and ketones > +2; 8) Concurrent requirement for any surgery requiring general anesthesia. Anatomic Exclusion Criteria Specific criteria are for patients who have angiograms available prior to randomization: 1. Severe vascular tortuosity or anatomy that would preclude the safe introduction of a guiding catheter, guiding sheath or stent placement; 2. Presence of a previously placed intravascular stent or graft in the ipsilateral distribution; 3. Presence of extensive or diffuse atherosclerotic disease involving the aortic arch and proximal common carotid artery that would preclude the safe introduction of a guiding catheter or guiding sheath; 4. An intraluminal filling defect (defined as an endolum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the composite of any stroke, MI, or death during a 30-day periprocedural period, or Intermittent claudication, TIA, or ipsilateral stroke through follow-up of up to three years.; | — |
Secondary
| Measure | Time frame |
|---|---|
| new DWI lesion, intrastent restenosis, incidence of cancer, severe infection; | — |
Countries
China
Contacts
Public ContactGuo Daqiao
Outcome results
None listed