A clinical investigation of SM-01 stenting versus balloon angioplasty for the treatment of superficial femoral artery disease.

UMIN ID: UMIN000003928

Registered date:20/07/2010

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: 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).
• Date of first enrollment: 2010/07/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

STENT
PTA

Outcome(s)

• Primary Outcome: Non-TVF(Target-vessel failure) rate at 1-year follow-up

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Johnson and Johnson K.K. Medical Company
• Source(s) of Monetary Support: Johnson and Johnson K.K. Medical Company