Unique ID issued by UMIN | UMIN000008533 |
---|---|
Receipt number | R000010001 |
Scientific Title | Randomized controlled trial about the clinical outcome between Carotid Wallstent and Precise stent in Carotid Artery Stenting |
Date of disclosure of the study information | 2012/07/25 |
Last modified on | 2013/06/10 19:13:11 |
Randomized controlled trial about the clinical outcome between Carotid Wallstent and Precise stent in Carotid Artery Stenting
Randomized controlled trial about the clinical outcome between Carotid Wallstent and Precise stent in Carotid Artery Stenting (Wakayama Stent Comparison Trial for Carotid Artery Stenting: WASCOT-CAS)
Randomized controlled trial about the clinical outcome between Carotid Wallstent and Precise stent in Carotid Artery Stenting
Randomized controlled trial about the clinical outcome between Carotid Wallstent and Precise stent in Carotid Artery Stenting (Wakayama Stent Comparison Trial for Carotid Artery Stenting: WASCOT-CAS)
Japan |
internal carotid artery stenosis
Neurosurgery |
Others
NO
To investigate whether different stent cell design affect the clinical outcome of carotid artery stenting or not
Safety,Efficacy
any ischemic stroke and severe disability or death by any causes within 30days after treatment
1. new ischemic lesions detected by diffusion weighted images within 7 days after the treatment
2. intrastent plaque protrusion detected by IVUS, angiogram, CT angiography or carotid ultrasound within 7 days after the treatment
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Device,equipment |
Carotid Wallstent
Precise stent
20 | years-old | <= |
80 | years-old | > |
Male and Female
1. High Risk Patient of CEA
Symptomatic (within 180 days from onset)
: >=50% Stenosis
Asymptomatic : >=80% Stenosis
2. Age >= 20 and <80 years old
3. Independent daily life (mRS<=2)
4. Available for anti-platelet agents
5. Feasible of distal protection (Filterwire EZ)
6. Treatable lesion either by using either Carotid Wallstent or Precise stent
Lesions with following two features are excluded from anatomical point of view.
a) lesions totally surrounded by calcified plaque
b) severe angulation between CCA-ICA (over 60 degree)
7. Available for MRI examination
8. CAS within 30 days after enrollment
9. Written informed consent
1. Previous treatment for the target lesion
2. Lesions considered to be non-atherosclerotic etiology
3. Recurrent symptom of cerebral ischemia within 48 hours before enrollment
4. Complete occlusion/pseudoocclusion
5. Coexistence of other symptomatic cerebral stenosis
6. Previous hemorrhagic stroke within 90 days before enrollment
7. Serological Creatinine over 2mg/dl
8. Pregnancy or possible pregnancy
9. Planned brain surgery or other endovascular treatment within 1 month
10. Inappropriate candidate for attending to the trial
200
1st name | |
Middle name | |
Last name | Tomoaki Tomoaki |
Wakayama Rosai Hospital
Neurosurgery
Kinomoto 93-1, Wakayama City, Japan
1st name | |
Middle name | |
Last name | Hideo Okada |
Wakayama Rosai Hospital
Neurosurgery
Kinomoto 93-1, Wakayama City, Japan
Wakayama Rosai Hospital Medical Research Center
Wakayama Rosai Hospital Medical Research Center
Other
NO
2012 | Year | 07 | Month | 25 | Day |
Unpublished
Enrolling by invitation
2012 | Year | 05 | Month | 18 | Day |
2012 | Year | 07 | Month | 25 | Day |
2012 | Year | 07 | Month | 25 | Day |
2013 | Year | 06 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010001
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |