UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multi-center registry evaluating the safety of carotid artery stenting in symptomatic and asymptomatic carotid artery stenosis patients in Japan
Title of the study (Brief title)	CASSIS Registry
Region	Japan

Condition
Condition	Carotid artery stenosis
Classification by specialty	Cardiology Neurology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of carotid artery stenting in carotid stenosis patients in the realworld setting.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of major adverse events (AMI, stroke and death) occurring within 48 hours, 30 days and 12 months post-procedure. Stroke symptoms which resolve within 24 hours will be excluded.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients for whom one of the following definitions apply: a. Presenting neurological symptoms and stenosis of 50% or greater in either the common or internal carotid artery as confirmed by ultrasound or angiography. b. Presenting no neurological symptoms but stenosis of 80% or greater in either the common or internal carotid artery as confirmed by ultrasound or angiography. Neurological symptoms refer to cerebral or retinal transient ischemic attack (TIA) or ischemic stroke. Stenosis is to be measured with the ESCT method when using ultrasound, and the NASCET method when measured by angiography. 2) Patients judged to be appropriate candidates for CAS by the attending physician 3) Patients who have given informed written consent to participate in the study and are 20 years or older at the time of consent.
Key exclusion criteria	4) Patients who have undergone CAS, CEA, PCI, EVT or vascular bypass within the past 30 days. 5) Patients currently enrolled or planning to enroll in clinical trial(s) that could affect the outcome of this study. 6) Patients for whom a follow up examination 30 days post-CAS would be difficult.
Target sample size	400

Research contact person
Name of lead principal investigator	Hiroyoshi Yokoi
Organization	Fukuoka Sanno Hospital
Division name	cardiovascular center
Address	3-6-45 Momochihama, Sawaraku, Fukuoka-shi
TEL	092-832-1100
Email	hiroyokoi@circus.ocn.ne.jp

Public contact
Name of contact person	Hiroyoshi Yokoi
Organization	A study group for therapy of carotid artery stenosis
Division name	CASSIS Registry Office
Address	3-6-45 Momochihama, Sawaraku, Fukuoka-shi
TEL	092-832-1100
Homepage URL
Email	cassis.registry@gmail.com

Sponsor
Institute	A study group for therapy of carotid artery stenosis
Institute
Department

Funding Source
Organization	A study group for therapy of carotid artery stenosis
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 19 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2015 Year 10 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	In multiple institutions throughout Japan, patients diagnosed with carotid artery stenosis who meet the study selection criteria will be prospectively, consecutively enrolled, and will undergo follow-up examinations at 30 days and 1 year after the index CAS procedure. Real-world clinical information on CAS-related complications, acute and 1-year safety outcomes, patient demographics, test devices and other devices used in treatment will be collected and analyzed. CAS will be performed in medical institutions that conform to the rules of practice defined in the study protocol, by physicians who conform to these same rules. Major clinical event adjudication, neurological assessments, and diagnostic imaging data interpretation will be performed by third parties who do not have patients enrolled in this study. Information regarding patients who are enrolled but do not ultimately undergo CAS treatment will be limited to the reason for cancellation and alternative treatment provided.

Management information
Registered date	2012 Year 05 Month 10 Day
Last modified on	2018 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009305