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Superficial Femoral Artery DiseaseSTROLLNCT00739102

S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease

A study testing S.M.A.R.T. ® Stent in people with Superficial Femoral Artery Disease, run by Cordis US Corp. at 1 site in United States.

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

A multi-center, non-randomized, single-arm, prospective trial evaluating the safety and effectiveness of the S.M.A.R.T.™ Nitinol Stent System implantation in approximately 250 patients with obstructive superficial femoral artery disease. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Superficial Femoral Artery Disease
What is being tested?
S.M.A.R.T. ® Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteUnited States
Study dates
Aug 2008to Apr 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Age >/= 30 years
  • For women of child bearing potential, a pregnancy test within 7 days prior to index procedure (the test results must be negative to be eligible).
  • Symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4) with a resting or exercise ABI </= 0.8.
  • A single superficial femoral artery lesion with > 50% stenosis or total occlusion.
  • Stenotic lesion or occluded length within the same vessel (one long or multiple serial lesions) >/= 4.0 cm to </= 15.0 cm, by visual estimate. The stenosis must be treatable with no more than two stents, minimizing the stent overlap whose combined length </= 170 mm.
  • Reference vessel diameter (RVD) >/= 4.0 mm and </= 6.0 mm by visual assessment.
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  • All lesions are to be located at least three centimeters proximal to the superior edge of the patella.
  • Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (< 50% stenosis) to the ankle or foot.
  • The guidewire is across the target lesion(s) and located intraluminally within the distal vessel.
  • Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined > 50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoropopliteal bypass graft must be successfully treated prior to treatment of the target lesion. This can be done just prior to treatment of the target lesion. Successful treatment is defined as <30% stenosis after either PTA or stenting of the inflow lesion. After treatment of the inflow lesion, if the peak to peak pressure gradient across the inflow lesion is </= 20mmHg and the peak to peak pressure gradient across the SFA target lesion is >/= 20mmHg, then the patient will be included in the study.
  • A patient with bilateral obstructive SFA disease is eligible for enrollment into the study.
  • Eligibility for standard surgical repair, if necessary.
  • A patient who requires a coronary intervention, should have it performed at least 7 days prior to the treatment of the target lesion.
  • Patient or authorized representative must provide written informed consent and written HIPAA authorization prior to initiation of study procedures.
  • Patient must be willing to comply with the specified follow-up evaluation schedule.

Who cannot join

  • Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days.
  • Receiving dialysis or immunosuppressant therapy.
  • Thrombolysis of the target vessel within 72 hours prior to the index procedure where complete resolution of the thrombus was not achieved.
  • Recent stroke within past 90 days.
  • Femoral, iliac or aortic aneurysm or aneurysm in the SFA or popliteal artery within past 5 years.
  • Required stent placement via a popliteal approach.
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  • Required stent placement across or within 0.5 cm of the SFA / PFA bifurcation.
  • 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.
  • Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
  • Previously deployed stent within the SFA of the target limb.
  • Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed.
  • Presence of thrombus prior to crossing the lesion
  • Tissue loss due to ischemic disease (Rutherford/Becker category 5 or 6)
  • Serum creatinine level >/= 2.5 mg/dl at time of screening visit
  • Known or suspected active infection at the time of the procedure
  • Bleeding diathesis
  • Presence of an aortic, iliac or femoral artificial graft
  • Life expectancy less than one year, or any other factors preventing clinical followup.
  • Use of cryoplasty, laser, or atherectomy devices on the target vessel at the time of index procedure
  • In-stent restenotic lesions at time of procedures.
  • Restenotic lesion that had previously been treated by atherectomy, laser, or cryoplasty within 90 days of the index procedure.
  • Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.
  • Patient is known to be pregnant, incarcerated, mentally incompetent, and/or alcohol or drug abuser.
  • Patient is currently participating in any other investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or future participation in such studies prior to the completion of this study.
  • Patient has had major surgical or interventional procedures unrelated to this study within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study. Interventional procedures performed to the ipsilateral iliac artery to provide access will be allowed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University Medical Center

    New York, New York, 10032

Other trials in United States

About this study

Official title: S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease (STROLL)

A multi-center, non-randomized, single-arm, prospective trial evaluating the safety and effectiveness of the S.M.A.R.T.™ Nitinol Stent System implantation in approximately 250 patients with obstructive superficial femoral artery disease.

Being tested
S.M.A.R.T. ® Stent
Keywords
Superficial Femoral Artery, Nitinol Self-Expandable Stent System

What participants receive

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

  • S.M.A.R.T. ® StentDevice

    The Cordis S.M.A.R.T.® Nitinol Stent System 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.

Study groups in NCT00739102
Study groupRoleWhat they receive
1ExperimentalS.M.A.R.T.® Nitinol Self-Expandable Stent System
Receives: Device: S.M.A.R.T. ® Stent

What is being measured

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

  1. 12-month Primary Patency Rate

    Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis >50% with a peak systolic velocity ratio >2.0 as measured by Duplex ultrasound.

    Measured: 12 months

  2. Primary Safety Endpoint

    Primary safety endpoint is defined as the rate of freedom from all causes of death, index limb amputation, and clinically driven target lesion revascularization (TLR) through 30 days. A clinically driven TLR is any intervention in the stented target lesion following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise ABI ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target lesion with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.

    Measured: 30 days

Secondary outcomes (11)

  1. Death Rate at 30-day Post Procedure

    Measured: 30 days

  2. Death at 12-month Post Procedure

    Measured: 12 months

  3. Index Limb Amputation at 30-day Follow up

    Index Limb Amputation is defined as surgical removal of all or part of the lower extremity from the toe up.

    Measured: 30 day

  4. Clinically Driven Target Vessel Revascularization (TVR) at 30-day Post Procedure

    A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.

    Measured: 30 days

  5. Clinically Driven Target Vessel Revascularization (TVR) at 12-month Post Procedure

    A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.

    Measured: 12 months

  6. Stent Fracture at 12-month Follow Up

    Stent fracture was assessed by x-ray evaluation.

    Measured: 12 months

  7. Index Limb Ischemia at 6-month Follow up

    Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.

    Measured: 6 months

  8. Index Limb Ischemia at 12-month Follow up

    Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.

    Measured: 12 months

  9. Rutherford/Becker Classification at 30-day Follow Up

    The Rutherford/Becker Classification is a commonly used clinical staging system which allows clinicians to describe and discuss patients with peripheral artery disease. The classification has seven stages as follows:

    1. Stage 0 - Asymptomatic, no hemodynamically significant occlusive disease
    2. Stage 1 - Mild claudication
    3. Stage 2 - Moderate claudication
    4. Stage 3 - Severe claudication
    5. Stage 4 - Ischemic rest pain
    6. Stage 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia
    7. Stage 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

    Measured: 30 days

  10. Rutherford / Becker Classification Category at 12-month Follow Up

    Measured: 12 months

  11. Major Adverse Events at 12-month Post Procedure

    Major adverse events included death, index limb ischemia, index limb amputation, clinically driven TLR, and significant embolic events, which were defined as causing end-organ damage.

    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 posted21 Aug 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionMay 2011
  4. Study completionApr 2013

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00739102
Sponsor's protocol ID
P05-6201
Acronym
STROLL
Status last verified
Mar 2014
First submitted
20 Aug 2008
Last updated
17 Apr 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing S.M.A.R.T. ® Stent in people with Superficial Femoral Artery Disease, run by Cordis US Corp. at 1 site in United States.

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 15 inclusion and 25 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 17 Apr 2014. 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 United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

12-month Primary Patency Rate (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT00739102.

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 17 Apr 2014.

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