Carotid Artery Stenting With Cilostazol Addition for Restenosis

Kobe City General Hospital707 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

707

Conditions

In-stent Restenosis After Carotid Artery Stenting

Interventions

Cilostazol or Non-CilostazolDRUG

Cilostazol group administrate 100-200mg/day per oral, unrestricted use of other antiplatelet agents and concomitant drugs.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Outcomes

Primary Outcomes

Presence or absence of in-stent restenosis within 2 years after CAS and time to occurrence

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.

Time frame: 2 years

Secondary Outcomes

Cardiovascular event, death, hemorrhagic event, in-stent restenosis, new out-stent stenosis, or retreatment of stented artery within 2 yrs

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

Time frame: 2 years

In-stent restenosis, new out-stent stenosis, or retreatment within 2 years

In-stent restenosis, new out-stent stenosis detected by ultrasound or CTA/DSA, or retreatment of stented artery within 2 years

Time frame: 2 years

hemorrhagic event within 2 years

hemorrhagic stroke, major hemorrhage required 2 unit or more transfusion

Time frame: 2 years

stroke within 2 years

any ischemic or hemorrhagic stroke

Time frame: 2 years

In-stent restenosis, new out-stent stenosis, or retreatment of stented artery, cardiovascular event, or death from any cause within 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

Time frame: 30 days

Data from ClinicalTrials.gov

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