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Arterial Occlusive DiseasesPhase 4SUPER SLNCT00235131

The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent

A Phase 4 study testing Smart Stent and Luminexx Stent in people with Arterial Occlusive Diseases, run by Cordis US Corp. at 2 sites in Germany.

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

This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System for the treatment of TASC C \& D superficial femoral artery long lesions (up to 22 cm) in comparison with the Bard® Luminexx™ 6F Vascular Stent as determined by the primary patency rate at 6 and 12 months post procedure. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Arterial Occlusive Diseases
What is being tested?
Smart Stent and Luminexx Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesGermany
Study dates
May 2005to May 2009
Phase
Phase 4
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptomatic leg ischemia by Rutherford classification (category 2, 3, 4 or 5); duration of intermittent claudication (category 2-3) should be at least 3 months.
  • One superficial femoral artery de novo or restenotic lesion (more than 70% stenosis or occlusions), with a lesion length of more than 5 to less than 22 cm.
  • Patent popliteal artery on the index side, i.e., single vessel runoff or better with at least one of three vessels patent to the lower 1/3 of the calf prior to the day of the procedure.

Who cannot join

  • Revascularisation involving the same limb within 30 days prior to the index procedure or a planned revascularisation within 30 days after the index procedure.
  • Patients having total occlusions of the iliac artery on the same side must be excluded.
  • Previously implanted stent(s) in the to be treated artery at the same site.
  • Requiring stent placement in the distal superficial femoral artery and the popliteal artery.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Gemeinschaftspraxis füsar Radiologische Diagnostik& Zentrum für Minimal Invasite Therapie am Jüdischen Krankenhaus Berlin

    Berlin, 13347

  • Universitat Leipzig Herzzentrum Abt. Für Klinische u. Intervent. Angiologie

    Leipzig, 04289

Other trials in Germany

About this study

Official title: A Clinical Investigation of the Cordis S.M.A.R.T. ™ CONTROL ™ Nitinol Stent System Versus the Bard® Luminexx™ 6F Vascular Stent for the Treatment of TASC C & D Superficial Femoral Artery Long Lesions

This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System for the treatment of TASC C \& D superficial femoral artery long lesions (up to 22 cm) in comparison with the Bard® Luminexx™ 6F Vascular Stent as determined by the primary patency rate at 6 and 12 months post procedure.

Read the detailed description

This is a German multi-center prospective, randomized, two-arm study evaluating performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System as compared to the C.R. Bard® Luminexx™ 6F Vascular Stent. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 200 patients will be entered into the study.

The study population will consist of approximately 200 symptomatic peripheral vascular disease patients with TASC C \& D SFA lesions. The disease will consist of symptomatic, long de novo or restenotic lesions (> 70% stenosis) and occlusions (5 - 22 cm) on diagnostic imaging. The lesion must not extend into the distal SFA and the popliteal artery. At least one distal popliteal artery must be patent as well as one calf vessel. Reference vessel diameter must be >= 4.0 to <= 6.0 mm.

Trial participants will be randomized to the Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System or to the Bard® Luminexx™ 6F Vascular Stent.

Patients will be followed for twelve months post-procedure. Study examinations will be done at screening, procedure time, discharge, six, and twelve months post procedure.

This study will be conducted over up to 15 investigational sites in Germany.

Being tested
Smart Stent, Luminexx Stent
Keywords
Peripheral Artery Occlusive Disease
Medical subject headings
Arterial Occlusive Diseases, Peripheral Arterial Occlusive Disease 1

What participants receive

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

  • Smart StentDevice

    Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System

  • Luminexx StentDevice

    Bard® Luminexx™ 6F Vascular Stent

Study groups in NCT00235131
Study groupRoleWhat they receive
1ExperimentalCordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System
Receives: Device: Smart Stent
2Active comparatorBard® Luminexx™ 6F Vascular Stent
Receives: Device: Luminexx Stent

What is being measured

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

  1. primary patency detectable by duplex ultrasound through the index lesion

    Measured: 12 months

Secondary outcomes (11)

  1. technical success

    Measured: time of deployment

  2. procedural success

    Measured: up to removal of catheter sheath

  3. procedural complications

    Measured: up to removal of catheter sheath

  4. Ankle Brachial Index

    Measured: discharge and 12 months

  5. primary patency

    Measured: 6 months

  6. binary restenosis

    Measured: 6 and 12 months

  7. stent fractures

    Measured: 6 and 12 months

  8. target lesion revascularisation

    Measured: 6 and 12 months

  9. target vessel revascularisation

    Measured: 6 and 12 months

  10. adverse events

    Measured: baseline, discharge, 6 and 12 months post procedure

  11. clinical categorization of chronic limb ischemia by means of the Rutherford classification

    Measured: discharge, 6 and 12 months post procedure

Timeline

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

  1. First posted10 Oct 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionMar 2008
  4. Study completionMay 2009

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00235131
Sponsor's protocol ID
EE04-02
Acronym
SUPER SL
Status last verified
Feb 2010
First submitted
4 Oct 2005
Last updated
4 Feb 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Smart Stent and Luminexx Stent in people with Arterial Occlusive Diseases, run by Cordis US Corp. at 2 sites in Germany.

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 3 inclusion and 4 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 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

primary patency detectable by duplex ultrasound through the index lesion (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 NCT00235131.

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 4 Feb 2010.

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