UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Johnson & Johnson K.K. Medical Company

Institute

Department

Personal name

Organization

Johnson & Johnson K.K. Medical Company

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

ENDO CORE

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

2011

Year

11

Month

28

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

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 related information

Registered date

2011

Year

11

Month

25

Day

Last modified on

2017

Year

05

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008001