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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003928
Receipt No. R000004707
Scientific Title A clinical investigation of SM-01 stenting versus balloon angioplasty for the treatment of superficial femoral artery disease.
Date of disclosure of the study information 2010/07/20
Last modified on 2017/05/12

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Basic information
Public title A clinical investigation of SM-01 stenting versus balloon angioplasty for the treatment of superficial femoral artery disease.
Acronym SM-01
Scientific Title A clinical investigation of SM-01 stenting versus balloon angioplasty for the treatment of superficial femoral artery disease.
Scientific Title:Acronym SM-01
Region
Japan

Condition
Condition Patient with intermittent claudication who shows no sign of improvement with exercise or drug treatment. The SFA lesion(s) should be de novo or restenotic (one long or multiple, serial native lesions with total length >= 40 mm and <= 150 mm).
Classification by specialty
Cardiology Vascular surgery Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The main objective is to evaluate the safety and efficacy of SM-01 stenting for the treatment of SFA lesions as compared to PTA.If SM-01 is used in a PTA-bailout patient, the case will be assessed separately.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Non-TVF(Target-vessel failure) rate at 1-year follow-up
Key secondary outcomes

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 PTA
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 1. Age >= 20 years.
2. Symptomatic leg ischemia by Rutherford Classification (category1, 2, or 3).
3. Lesion length >= 40 mm to <= 150 mm. (must be treatable with no more than two SM-01 stents. Overlap should be about 1cm if two stents are used)
4. Reference vessel diameter (RVD) >= 4.0 mm and <= 7.0 mm.
5. All lesions are to be located >= 3.0 cm proximal to the superior edge of the patella, and >= 1.0 cm distal to the SFA / PFA bifurcation.
6. >= 50% stenosis or total occlusion.
7. Patent infrapopliteal and popliteal arteries, i.e., single-vessel runoff or better with at least one of three vessels patent (< 50% stenosis) to the ankle or foot.
8. Patient or legally authorized representative must provide written informed consent prior to initiation of study procedures.
9. A patient with bilateral obstructive SFA disease is eligible for enrollment into the study. If a patient with bilateral disease is enrolled, the target limb will be the more severe limb. The more severe limb will be selected according to clinical symptomatology. If clinical symptomatology is similar, the more clinically severe lesion will be selected. The contralateral procedure should not be done until at least 30 days after the index procedure of the more severe limb was attempted.
Key exclusion criteria 1. Recent hemorrhagic disease within the past 3 months.
2. Aneurysm in the SFA or popliteal artery.
3. Acute limb occlusion.
4. Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as severe calcification which is resistant to stenting, or for in-stent restenosis.
5. Poor iliac or common femoral "inflow".(However, intervention to restore adequate blood flow prior to the treatment of the study lesion is allowed.)
6. Known allergies to aspirin, heparin, or ticlopidine, or bleeding diathesis.
7. Patients unable or unwilling to tolerate anticoagulant or antiplatelet therapy.
8. Patients unable or unwilling to tolerate contrast agents used in intravascular procedures.
9. Allergic to nitinol or tantalum.
10. Women who are pregnant or lactating, or of child bearing potential, or with a desire to be a parent during the study period.
11. Significant vessel tortuosity or other parameters prohibiting access to the lesion or which would prevent delivery of the stent device.
12. Revascularization involving the same limb 30 days prior to the index procedure or a planned re-vascularization within 30 days after the index procedure.
13. Previously implanted stent(s) at the same site in the artery to be treated.
14. Requiring stent placement in the distal SFA or popliteal artery.
15. Presence of a femoral artificial graft.
16. History of participating in any other clinical study within 1 year.
17. Life expectancy less than 3 years, or any other factors preventing clinical follow-up.
18. Receiving dialysis or immunosuppressant therapy
19. Serum creatinine level >= 2.0 mg/dL before procedure.
20. A principal investigator or a co-principal investigator determines that patient is unsuitable for this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinsuke Nanto
Organization Graduate School of Medicine/Faculty of Medicine, Osaka University
Division name Advanced Cardiovascular Therapeutics
Zip code
Address 2-15, Yamadaoka, Suita-shi, Osaka, Japan
TEL 06-6879-3441
Email s.nanto@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Iizumi Misuzu
Organization Johnson and 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 and Johnson K.K. Medical Company
Institute
Department

Funding Source
Organization Johnson and Johnson K.K. Medical Company
Organization
Division
Category of Funding Organization Profit organization
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
2010 Year 07 Month 20 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
2010 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2014 Year 08 Month 18 Day
Date of closure to data entry
2014 Year 09 Month 30 Day
Date trial data considered complete
2014 Year 11 Month 19 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 07 Month 20 Day
Last modified on
2017 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004707

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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