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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006774
Receipt No. R000008001
Scientific Title Clinical Trial in G-008 Femoro-popliteal Self-Expanding Stent System(G-008)
Date of disclosure of the study information 2011/11/28
Last modified on 2017/05/19

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Basic information
Public title Clinical Trial in G-008 Femoro-popliteal Self-Expanding Stent System(G-008)
Acronym G-008
Scientific Title Clinical Trial in G-008 Femoro-popliteal Self-Expanding Stent System(G-008)
Scientific Title:Acronym G-008
Region
Japan

Condition
Condition Peripheral Arterial Disease in superficial femoral artery (SFA) and/or proximal popliteal artery
Classification by specialty
Cardiology Vascular surgery Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of efficacy and safety of the G-008
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Non-TLF rate during 12 months after procedure
Key secondary outcomes Device success, Procedure success, Evaluation of ABI, Rutherford classification, Patency rate, Acute gain, QOL

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Stent
Interventions/Control_2 POBA
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 Inclusion Criteria of Patient:
1. Age >=20, male or female.
2. Getting informed consent from a patient or legal guardian.
3. Patient who is willing and able to comply with all follow-up requirements.
4. One lesion per limb.
5. Maintaining patency of ipsilateral iliac artery.
6. Rutherford Classification Category 2-4 (including ischemic pains at rest).
7. Maintaining patency of ipsilateral mid/distal popliteal artery and at least one of fibular or tibial arteries with no planned intervention.

Inclusion Criteria of Lesion:
1. Significant stenotic lesion in the femoro-popliteal artery.
2. Target lesion apart from the origin of SFA >=10mm.
3. Lesion length >=40mm to <=150mm.
4. Reference vessel diameter >=4.0mm and <=7.5mm.
5. No obvious thrombus observed in the target vessel by angiography.
Key exclusion criteria Exclusion Criteria of Patient:
1. Distal artery of the target vessel previously treated by stenting or bypass surgery.
2. Patient who is diagnosed with Acute Limb Ischemia (ALI) within seven days before treatment.
3. ABI >=0.9 at rest and post exercise.
4. Rutherford Classification Category 0, 1, 5 or 6.
5. Inability to tolerate antithrombotic or antiplatelet therapies.
6. Previous history of allergy to materials used in the investigational device.
7. Allergic to pharmaceuticals used in diagnostic or interventional catheterization.
8. Serum creatinine >2.0mg/dL.
9. Patient who is judged to be less likely to be able to comply with follow-up requirements specified in the protocol due to the risk of other comorbidities by principal investigator or subinvestigators.
10. Patient who is pregnant or has a possibility of pregnancy.
11. Known bleeding diathesis.
12. Patient enrolled in any other clinical trial, except for those whose follow-up have been completed.
13. Patient who is determined to be unsuitable for this study by principal investigator or subinvestigators.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Yokoi
Organization Kishiwada Tokushukai Hospital
Division name Cardiovascular
Zip code
Address 4-27-1 Kamori-cho, Kishiwada, Osaka, Japan
TEL 072-445-9915
Email yyokoi@bb.emobile.jp

Public contact
Name of contact person
1st name
Middle name
Last name Iizumi Misuzu
Organization Johnson & Johnson K.K. Medical Company
Division name Clinical Operation
Zip code
Address 5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo, Japan
TEL 03-4411-6789
Homepage URL
Email MIIZUMI@its.jnj.com

Sponsor
Institute Johnson & Johnson K.K. Medical Company
Institute
Department

Funding Source
Organization Johnson & Johnson K.K. Medical Company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor ENDO CORE
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
2011 Year 11 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 Completed
Date of protocol fixation
2011 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 25 Day
Last modified on
2017 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008001

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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