A Clinical Investigation of SM-01 Stenting Versus PTA for the Treatment of Superficial Femoral Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01183117
Recruitment Status : Completed
First Posted : August 17, 2010
Last Update Posted : April 2, 2015
Information provided by (Responsible Party):
Johnson & Johnson K.K. Medical Company

Brief Summary:
The main objective is to evaluate the safety and efficacy of SM-01 stenting (Cordis S.M.A.R.T.™ Nitinol Stent System) for the treatment of SFA lesions as compared to PTA (balloon angioplasty). If SM-01 is used in a PTA-bailout patient, the case will be assessed separately.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Diseases Device: SM-01 Device: PTA Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Investigation of SM-01 Stenting Versus PTA for the Treatment of Superficial Femoral Artery Disease
Study Start Date : July 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: SM-01 Device: SM-01
SM-01 is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
Active Comparator: PTA Device: PTA
balloon angioplasty

Primary Outcome Measures :
  1. Non-TVF(Target-vessel failure) rate [ Time Frame: 12 Months ]
    The primary endpoint will be freedom from TVF defined as any events of clinical driven (confirmed by duplex ultrasound or angiography) TLR/TVR, procedure failure, amputation of the target lesion's leg, procedure or device related death, occlusion of target lesion, or > 70% restenosis of target lesion.

Secondary Outcome Measures :
  1. Procedure Success rate [ Time Frame: 12 Months ]
  2. Procedure Success rate for Bailout [ Time Frame: 12 Months ]
  3. Difference between pre and post proceduer of ABI [ Time Frame: 12 Months ]
  4. Difference between pre and post procedure of Rutherford Categories [ Time Frame: 12 Months ]
  5. Non-TLR/TVR rate [ Time Frame: 12 Months ]
  6. Primary Patency rate [ Time Frame: 12 Months ]
  7. Stent Fracture rate [ Time Frame: 12 Months ]
  8. Difference between pre and post procedure of QOL (SF-36) [ Time Frame: 12 Months ]
  9. Major Clinical Event rate [ Time Frame: 12 Months ]

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01183117

Toho University Ohashi Medical Center
Meguro-ku, Tokyo, Japan
Sponsors and Collaborators
Johnson & Johnson K.K. Medical Company
Principal Investigator: Hidehiko Hara, MD Toho University Ohashi Medical Center

Responsible Party: Johnson & Johnson K.K. Medical Company Identifier: NCT01183117     History of Changes
Other Study ID Numbers: SM-01
First Posted: August 17, 2010    Key Record Dates
Last Update Posted: April 2, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arterial Occlusive Diseases