Carotid Artery Stenting With Cilostazol Addition for Restenosis

In-stent Restenosis After Carotid Artery Stenting Clinical Trial

— CAS-CARE  

Official title:

Effect of Cilostazol on In-stent Restenosis After Carotid Artery Stenting; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261234
• Other study ID #: TRIBRAIN1010
• Secondary ID: UMIN000004705
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: September 2019

Study information

• Verified date: October 2019
• Source: Kobe City General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 707
• Est. completion date: September 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• In-stent Restenosis After Carotid Artery Stenting

Intervention

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

Locations

Country	Name	City	State
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo

Sponsors (13)

Lead Sponsor	Collaborator
Kobe City General Hospital	Chiba University, Foundation for Biomedical Research and Innovation, Fukuoka University, Kobe University, Kyoto University, Mie University, Nagasaki University, Nagoya University, Okayama University, Osaka University, Wakayama Medical University, Yamaguchi University Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	hemorrhagic event within 2 years	hemorrhagic stroke, major hemorrhage required 2 unit or more transfusion	2 years
Secondary	stroke within 2 years	any ischemic or hemorrhagic stroke	2 years
Secondary	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	30 days
Secondary	Severe in-stent restenosis within 2 yrs	70% or more in-stent restenosis, diagnosed by ultrasound or DSA/CTA,	2 yeras
Secondary	Change from baseline in max-IMT in both common carotid arteries	Intima-Media thickness of common carotid artery measured by ultrasound	2 years