Carotid Artery Stenting With Cilostazol Addition for Restenosis
关键词
抽象
描述
Restenosis after carotid artery stenting (CAS) is a critical issue. Cilostazol can reduce restenosis after interventions in coronary or femoropopliteal arteries. The investigators confirmed and published periprocedural cilostazol administration reduced incidences of in-stent restenosis (ISR) or target vessel revascularization (TVR) after CAS, retrospectively.
CAS-CARE study is Multicenter Prospective Ranodomized Controlled Study. Patients, scheduled for CAS within 30 days, 50% or more symptomatic carotid stenosis or 80% or more asymptomatic carotid stenosis, will enroll and randomize by cilostazol/non-cilostazol group. 900 patients will be enrolled for 2 years and followed 2 years with in-stent restenosis after CAS, evaluated by carotid ultrasound and angiography. And, evaluate cardiovascular events, including stroke, myocardial infarction, and hemorrhagic events in periprocedural period and followed period. In this study, ISR is diagnosed by ultrasound and DSA/CTA. Equivalence of CTA to ultrasound will be studied.
日期
| 最后验证: | 09/30/2019 |
| 首次提交: | 12/10/2010 |
| 提交的预估入学人数: | 12/14/2010 |
| 首次发布: | 12/15/2010 |
| 上次提交的更新: | 10/13/2019 |
| 最近更新发布: | 10/15/2019 |
| 实际学习开始日期: | 11/30/2010 |
| 预计主要完成日期: | 02/28/2019 |
| 预计完成日期: | 08/31/2019 |
状况或疾病
干预/治疗
Drug: Cilostazol or Non-Cilostazol
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Cilostazol group Continuous administration of cilostazol (unrestricted use of other antiplatelet agents and concomitant drugs) | |
| Active Comparator: Non-Cilostazol group Antiplatelet agent other than cilostazol (unrestricted use of concomitant drugs) |
资格标准
| 有资格学习的年龄 | 45 Years 至 45 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 50% or more symptomatic carotid artery stenosis or 80% or more asymptomatic carotid artery stenosis - scheduled for carotid artery stenting within 30 days - 45 or more years-old and less than 80 years old - antiplatelet agents can be administratered orally - follow-up is anticipated possible for 2 years after CAS - self-supporoted in daily activities (modified Rankin Scale 2 or less) - patients who have given informed consent to participation in the study Exclusion Criteria: - received endovascular interevention - scheduled for bilateral carotid intervention - aortitis or cvasculitis - congessive heart failure - ischemic stroke within 48 hours - hemorrhagic stroke within 90 days - renal failure |
结果
主要结果指标
1. Presence or absence of in-stent restenosis within 2 years after CAS and time to occurrence [2 years]
次要成果指标
1. Cardiovascular event, death, hemorrhagic event, in-stent restenosis, new out-stent stenosis, or retreatment of stented artery within 2 yrs [2 years]
2. In-stent restenosis, new out-stent stenosis, or retreatment within 2 years [2 years]
3. hemorrhagic event within 2 years [2 years]
4. stroke within 2 years [2 years]
5. In-stent restenosis, new out-stent stenosis, or retreatment of stented artery, cardiovascular event, or death from any cause within 30 days [30 days]
6. Severe in-stent restenosis within 2 yrs [2 yeras]
7. Change from baseline in max-IMT in both common carotid arteries [2 years]
