UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical investigation of SM-01 stenting versus balloon angioplasty for the treatment of superficial femoral artery disease.
Title of the study (Brief title)	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	Shinsuke Nanto
Organization	Graduate School of Medicine/Faculty of Medicine, Osaka University
Division name	Advanced Cardiovascular Therapeutics
Address	2-15, Yamadaoka, Suita-shi, Osaka, Japan
TEL	06-6879-3441
Email	s.nanto@gmail.com

Public contact
Name of contact person	Iizumi Misuzu
Organization	Johnson and Johnson K.K. Medical Company
Division name	Clinical Operation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 03 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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