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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041208
Receipt No. R000047055
Scientific Title Patient-level meta-analysis of mortality from paclitaxel-containing device in Japanese patients with symptomatic superficial femoral artery disease.
Date of disclosure of the study information 2020/08/04
Last modified on 2020/07/25

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Basic information
Public title Long-term safety of paclitaxel containing devices in Japan
Acronym The use of paclitaxel containing devices and mortality
Scientific Title Patient-level meta-analysis of mortality from paclitaxel-containing device in Japanese patients with symptomatic superficial femoral artery disease.
Scientific Title:Acronym META-JAPAN
Region
Japan

Condition
Condition Peripheral artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of safety of paclitaxel containing devices on the long-term prognosis
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cumulative 5year all cause death
Key secondary outcomes

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
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Eligible trials were limited to approved devices as of March 2019 for use in the femoropopliteal artery, had a follow- up period of >1 year, and were conducted in Japan under good clinical practice (GCP) or good post-marketing study practice (GPSP).
Key exclusion criteria Clinical trials
1. not approved device in Japan
2. not conducted under GCP or GPSP guidance
Target sample size 2500

Research contact person
Name of lead principal investigator
1st name Masato
Middle name
Last name Nakamura
Organization Toho University, Ohashi Medical Center
Division name Division of cardiovascular Medicine
Zip code 153-8515
Address 2-22-36 Ohashi Meguroku Tokyo 153-8515 Japan
TEL 03-3468-1251
Email masato@oha.toho-u.ac.jp

Public contact
Name of contact person
1st name Masato
Middle name
Last name Nakamura
Organization Toho University, Oahshi Medical Center
Division name Division of Cardiovascular Medicine
Zip code 153-8515
Address 2-22-36 Ohashi Meguroku Tokyo 153-8515 Japan
TEL 0334681251
Homepage URL
Email masato@oha.toho-u.ac.jp

Sponsor
Institute Toho University
Institute
Department

Funding Source
Organization Grant from MHLW
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Toho University, Faculty of Medicine
Address 5-21-16 Omori Nishi Otaku Tokyo 143-8540 Japan
Tel 0337624151
Email masato@oha.toho-u.ac.jp

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
2020 Year 08 Month 04 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 2599
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
2019 Year 11 Month 01 Day
Date of IRB
2019 Year 12 Month 03 Day
Anticipated trial start date
2019 Year 12 Month 14 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Six companies had Japanese clinical trial data on endovascular treatment for symptomatic superficial femoral artery disease. With the corporation of the companies, individual data from all trials will be integrated and a patient-level meta-analysis will be conducted.
Estimated PTXD are 1153 cases, including 2 types of DCB (n = 388) and 2 types of DES (n = 1,014), non-PTXD are 894 cases, bare metal stent (n = 996) and balloon angioplasty (n = 201). A primary endpoint is all cause death and cumulative mortality will be estimated by the Kaplan-Meier curve. Five-year mortality with PTXD and non-PTXD will be compared to the log-rank test. Secondary endpoints are cumulative incidence of amputation and cause of death. Death will be classified as cardiovascular and non-cardiovascular. Non-cardiovascular death will be further classified into malignancy, infectious diseases and others.

Management information
Registered date
2020 Year 07 Month 25 Day
Last modified on
2020 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047055

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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