Carotid Artery Stenting With Cilostazol Addition for Restenosis
- Conditions
- In-stent Restenosis After Carotid Artery Stenting
- Interventions
- Registration Number
- NCT01261234
- Lead Sponsor
- Kobe City General Hospital
- Brief Summary
CAS-CARE study was conducted to evaluate the inhibitory effect of cilostazol, compared to that of other antiplatelet drugs, on in-stent restenosis following carotid artery stenting (CAS) in patients scheduled to undergo CAS. Study design is Multicenter Prospective Ranodomized Controlled Study, rondomized by cilostazol/non-cilostazol group prior to CAS. 900 patients will be enrolled for 2 years and followed 2 years with in-stent restenosis after CAS, evaluated by carotid ultrasound and angiography.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 707
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cilostazol group Cilostazol or Non-Cilostazol Continuous administration of cilostazol (unrestricted use of other antiplatelet agents and concomitant drugs) Non-Cilostazol group Cilostazol or Non-Cilostazol Antiplatelet agent other than cilostazol (unrestricted use of concomitant drugs)
- Primary Outcome Measures
Name Time Method Presence or absence of in-stent restenosis within 2 years after CAS and time to occurrence 2 years Difinition of endpoint is 50% or more in-stent restenosis detected by carotid ultrasound or angiopraphy. In cases restenosis does not occur, the final observation point will be used as the final evaluation point.
- Secondary Outcome Measures
Name Time Method stroke within 2 years 2 years any ischemic or hemorrhagic stroke
In-stent restenosis, new out-stent stenosis, or retreatment within 2 years 2 years In-stent restenosis, new out-stent stenosis detected by ultrasound or CTA/DSA, or retreatment of stented artery within 2 years
In-stent restenosis, new out-stent stenosis, or retreatment of stented artery, cardiovascular event, or death from any cause within 30 days 30 days Any peri-procedural events; in-stent restenosis, new out-stent stenosis, or retreatment of stented artery, cardiovascular event(stroke, myocardial infarction), or death from any cause
hemorrhagic event within 2 years 2 years hemorrhagic stroke, major hemorrhage required 2 unit or more transfusion
Cardiovascular event, death, hemorrhagic event, in-stent restenosis, new out-stent stenosis, or retreatment of stented artery within 2 yrs 2 years Any events, including death, cardiovascular event(stroke, myocardial infarction), hemorrhagic event, in-stent restenosis, new out-stent stenosis, retreatment of stented artery, within 2 years
Severe in-stent restenosis within 2 yrs 2 yeras 70% or more in-stent restenosis, diagnosed by ultrasound or DSA/CTA,
Change from baseline in max-IMT in both common carotid arteries 2 years Intima-Media thickness of common carotid artery measured by ultrasound
Trial Locations
- Locations (1)
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan