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Peripheral Vascular DiseasesPhase 3NCT01183117

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

A Phase 3 study testing SM-01 and PTA in people with Peripheral Vascular Diseases, run by Johnson & Johnson K.K. Medical Company at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Peripheral Vascular Diseases
What is being tested?
SM-01 and PTA
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteJapan
Study dates
Jul 2010to Aug 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >= 20 years.
  • Symptomatic leg ischemia by Rutherford Classification (category1, 2, or 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)
  • Reference vessel diameter (RVD) >= 4.0 mm and <= 7.0 mm.
  • 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.
  • >= 50% stenosis or total occlusion.
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  • 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.
  • Patient or legally authorized representative must provide written informed consent prior to initiation of study procedures.
  • 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.

Who cannot join

  • Recent hemorrhagic disease within the past 3 months.
  • Aneurysm in the SFA or popliteal artery.
  • Acute limb occlusion.
  • 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.
  • Poor iliac or common femoral "inflow".(However, intervention to restore adequate blood flow prior to the treatment of the study lesion is allowed.)
  • Known allergies to aspirin, heparin, or ticlopidine, or bleeding diathesis.
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  • Patients unable or unwilling to tolerate anticoagulant or antiplatelet therapy.
  • Patients unable or unwilling to tolerate contrast agents used in intravascular procedures.
  • Allergic to nitinol or tantalum.
  • Women who are pregnant or lactating, or of child bearing potential, or with a desire to be a parent during the study period.
  • Significant vessel tortuosity or other parameters prohibiting access to the lesion or which would prevent delivery of the stent device.
  • Revascularization involving the same limb 30 days prior to the index procedure or a planned re-vascularization within 30 days after the index procedure.
  • Previously implanted stent(s) at the same site in the artery to be treated.
  • Requiring stent placement in the distal SFA or popliteal artery.
  • Presence of a femoral artificial graft.
  • History of participating in any other clinical study within 1 year.
  • Life expectancy less than 3 years, or any other factors preventing clinical follow-up.
  • Receiving dialysis or immunosuppressant therapy
  • Serum creatinine level >= 2.0 mg/dL before procedure.
  • A principal investigator or a co-principal investigator determines that patient is unsuitable for this study.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Toho University Ohashi Medical Center

    Meguro-ku, Tokyo

Other trials in Japan

About this study

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.

Being tested
SM-01, PTA
Medical subject headings
Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SM-01Device

    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.

  • PTADevice

    balloon angioplasty

Study groups in NCT01183117
Study groupRoleWhat they receive
SM-01ExperimentalNot described
Receives: Device: SM-01
PTAActive comparatorNot described
Receives: Device: PTA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Non-TVF(Target-vessel failure) rate

    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.

    Measured: 12 Months

Secondary outcomes (9)

  1. Procedure Success rate

    Measured: 12 Months

  2. Procedure Success rate for Bailout

    Measured: 12 Months

  3. Difference between pre and post proceduer of ABI

    Measured: 12 Months

  4. Difference between pre and post procedure of Rutherford Categories

    Measured: 12 Months

  5. Non-TLR/TVR rate

    Measured: 12 Months

  6. Primary Patency rate

    Measured: 12 Months

  7. Stent Fracture rate

    Measured: 12 Months

  8. Difference between pre and post procedure of QOL (SF-36)

    Measured: 12 Months

  9. Major Clinical Event rate

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionSep 2012
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01183117
Sponsor's protocol ID
SM-01
Status last verified
Mar 2015
First submitted
1 Aug 2010
Last updated
2 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Iida O, Urasawa K, Komura Y, Soga Y, Inoue N, Hara H, Yajima J, Nakamura S, Ohki T, Ando H, Hirano K, Horita Y, Kichikawa K, Yokoi Y, Miyamoto A, Nakamura M, Takahara M, Mano T, Nanto S. Self-Expanding Nitinol Stent vs Percutaneous Transluminal Angioplasty in the Treatment of Femoropopliteal Lesions: 3-Year Data From the SM-01 Trial. J Endovasc Ther. 2019 Apr;26(2):158-167. doi: 10.1177/1526602819826591. Epub 2019 Jan 31.

    PubMed 30702021

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SM-01 and PTA in people with Peripheral Vascular Diseases, run by Johnson & Johnson K.K. Medical Company at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-TVF(Target-vessel failure) rate (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01183117, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2015.

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Clinical Trial NCT01183117 | AzTrials