UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003752
Receipt No. R000004545
Scientific Title Carotid artery stenting performed by cardiologists in Japan
Date of disclosure of the study information 2010/06/15
Last modified on 2014/06/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Carotid artery stenting performed by cardiologists in Japan
Acronym CASCARD
Scientific Title Carotid artery stenting performed by cardiologists in Japan
Scientific Title:Acronym CASCARD
Region
Japan

Condition
Condition Carotid Artery Stenosis
Classification by specialty
Cardiology Neurology Vascular surgery
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess safety and efficacy of Angioguard and Precise stent system in carotid stenting (CAS) performed by cardiologists in Japan
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Cumulative incidence of death, stroke or myocardial infarction within 30 days
Key secondary outcomes Success rate of CAS,
Other complications

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Carotid artery stenting using Angioguard and Precise system
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 High risk patients for carotid endarterectomy.
carotid stenosis >50% of symptomatic or >80% of asymptomatic patients
Key exclusion criteria Those who did not undergo CAS.
Target sample size 350

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Ikari
Organization Tokai University
Division name Cardiovascular medicine
Zip code
Address 143 Shimokasuya Isehara, Japan
TEL 0463-93-1121
Email ikari@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sachiko Yajima
Organization Tokai University
Division name Cardiovascular medicine
Zip code
Address 143 Shimokasuya Isehara Kanagawa
TEL 0463-93-1121
Homepage URL
Email s.yajima@tokai-u.jp

Sponsor
Institute Tokai University
Institute
Department

Funding Source
Organization Johnson and Johnson
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization USA

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 三井記念病院(東京都)
福岡東医療センター(福岡県)
福岡和白病院(福岡県)
時計台記念病院(北海道)
昭和大学横浜市北部病院(神奈川県)
旭川医科大学病院(北海道)
小倉記念病院(福岡県)
岸和田徳州会病院(大阪府)
大阪労災病院(大阪府)
岡山病院機構 岡山医療センター(岡山県)
心臓病センター 榊原病院(岡山県)
豊橋ハートセンター(愛知県)
(財)米沢三友堂病院(山形県)
湘南鎌倉総合病院(神奈川県)
大崎病院 東京ハートセンター(東京都)
奈良県立三室病院(奈良県)
三木市立三木市民病院(兵庫県)
長野県厚生連 篠ノ井総合病院(長野県) 
あかね会土谷総合病院(広島県)
帝京大学医学部附属溝口病院第4内科(神奈川県)
東京北病院(東京都)
春日部中央総合病院(埼玉県)
中通総合病院(秋田県)
国家公務員共済組合連合会平塚共済病院(神奈川県)
医療法人秀和会秀和綜合病院(埼玉県)
沖縄県立北部病院(沖縄県)
財団法人星総合病院(福島県)
袋井市立袋井市民病院(静岡県)
社会福祉法人仁生社江戸川病院(東京都)
医療法人福井心臓血圧センター福井循環器病院(福井県)
医療法人社団石鎚会田辺中央病院(和歌山県)
医療法人愛心会大隅鹿屋病院(鹿児島県)
茨城県厚生農業協同組合連合会総合病院取手協同病院(茨城県)
東京女子医科大学病院(東京都)
静岡済生会総合病院(静岡県)
医療法人柏堤会戸塚共立第2病院(千葉県)
医療法人青洲会福岡青洲会病院(福岡県)
船橋市立医療センター(千葉県)
社団法人明石市医師会立明石医療センター(兵庫県)
医療法人徳洲会茅ケ崎徳洲会総合病院(神奈川県)
独立行政法人労働者健康福祉機構熊本労災病院(熊本県)
三重ハートセンター(三重県)
近江八幡市立総合医療センター(滋賀県)
さいたま赤十字病院(埼玉県)
医療法人社団浅ノ川金沢循環器病院(石川県)
大垣市民病院(岐阜県)
埼玉県立循環器・呼吸器病センター(埼玉県)
医療法人社団洛和会洛和会丸太町病院(京都府)
社会福祉法人京都社会事業財団京都桂病院(京都府)
医療法人渓仁会手稲渓仁会病院(北海道)
国家公務員共済組合連合会横浜南共済病院(神奈川県)
医療法人社団高清会高井病院(奈良県)
社会福祉法人恩賜財団済生会横浜市東部病院(神奈川県)
医療法人社団木下会千葉西総合病院 (千葉県)

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results CAS performed by cardiologists in Japan was retrospectively analyzed in a total of 704 cases. Death or any stroke at 30 days was 2.7% in asymptomatic and 5.5% in symptomatic patients.
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

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
2010 Year 10 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information Cardiovasc Interv Ther. 2013 Jan;28(1):37-44. doi: 10.1007/s12928-012-0134-z. Epub 2012 Sep 26.

Management information
Registered date
2010 Year 06 Month 14 Day
Last modified on
2014 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004545

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.