UMIN-CTR Clinical Trial

Public title

A multi-center registry evaluating the safety of carotid artery stenting in symptomatic and asymptomatic carotid artery stenosis patients in Japan

Acronym

CASSIS Registry

Scientific Title

A multi-center registry evaluating the safety of carotid artery stenting in symptomatic and asymptomatic carotid artery stenosis patients in Japan

Scientific Title:Acronym

CASSIS Registry

Region

Japan

Condition

Carotid artery stenosis

Classification by specialty

Cardiology	Neurology	Neurosurgery

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hiroyoshi Yokoi

Organization

Fukuoka Sanno Hospital

Division name

cardiovascular center

Zip code

Address

3-6-45 Momochihama, Sawaraku, Fukuoka-shi

TEL

092-832-1100

Email

hiroyokoi@circus.ocn.ne.jp

Name of contact person

1st name
Middle name
Last name	Hiroyoshi Yokoi

Organization

A study group for therapy of carotid artery stenosis

Division name

CASSIS Registry Office

Zip code

Address

3-6-45 Momochihama, Sawaraku, Fukuoka-shi

TEL

092-832-1100

Homepage URL

Email

cassis.registry@gmail.com

Institute

A study group for therapy of carotid artery stenosis

Institute

Department

Personal name

Organization

A study group for therapy of carotid artery stenosis

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

05

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2012

Year

04

Month

19

Day

Date of IRB

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

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.

Registered date

2012

Year

05

Month

10

Day

Last modified on

2018

Year

05

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009305