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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023801
Receipt No. R000027424
Scientific Title Meta-analysis of BVS and EES: very long term result
Date of disclosure of the study information 2016/08/28
Last modified on 2016/08/28

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Basic information
Public title Meta-analysis of BVS and EES: very long term result
Acronym Meta-analysis of BVS and EES: very long term result
Scientific Title Meta-analysis of BVS and EES: very long term result
Scientific Title:Acronym Meta-analysis of BVS and EES: very long term result
Region
Japan

Condition
Condition Coronary Artery Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Several trials comparing bioabsorbable scaffold (BVS) and everolimus-eluting stent (EES) in patients with coronary artery disease is ongoing, and there are some short-term results stating the risk for acute scaffold thrombosis in the BVS. Besides, the risk for the very late scaffold thrombosis risk, occurring beyond 1-year is unknown, because few studies reported the long-term after BVS implantation, and the number of the enrolled patients in the each study is limited.
Therefore, we conducted a meta-analysis comparing the BVS and the EES regarding stent/scaffold thrombosis and target lesion failure in an attempt to address the very late adverse events of these devices.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stent/scaffold Thrombosis
Key secondary outcomes Target Lesion Failure

Base
Study type Others,meta-analysis etc

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
0 years-old <=
Age-upper limit
150 years-old >=
Gender Male and Female
Key inclusion criteria We searched all reported trials comparing Absorb bioabsorbable vascular scaffold (BVS) and everolimus-eluting stent (EES), and single-arm study evaluated the Absorb BVS or EES, with beyond 1 year results after coronary stent implantation. We identified relevant studies by searching PubMed, the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, conference proceedings, and presentations from major cardiovascular meetings using the keywords "biosbsorbable", "bioresorbable", "scaffold", "everolimus", and "stent", without language restrictions. We also manually checked reference lists of the identified reports and relevant reviews.
From the gathered studies, randomized controlled trials (RCT) and observational study comparing the effect of Absorb BVS and EES on ST or TLF were extracted. Furthermore, studies evaluated Absorb BVS or everolimus-eluting stent as a single-arm design with the results of ST or TLF with enough 2-year follow up were also extracted to calculate the estimated event rate of the outcome measure between 1 and 2 year from device implantation.

Key exclusion criteria Studies without enough 2-year follow-up were excluded.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kimura
Organization Kyoto Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoinkawaharamachi, Sakyo-ku, Kyoto
TEL 075-751-4255
Email taketaka@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiaki Toyota
Organization Kyoto Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoinkawaharamachi, Sakyo-ku, Kyoto
TEL 075-751-4255
Homepage URL
Email totoyota@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Kyoto Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Cardiovascular Medicine, Kyoto Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 08 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information beyond 1year and 2year result

Management information
Registered date
2016 Year 08 Month 28 Day
Last modified on
2016 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027424

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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