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The Study to Compare SMART Nitinol Stent and Balloon Angioplasty (SIT-UP)

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: NCT00309595
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : June 12, 2009
Information provided by:
Cordis Corporation

Brief Summary:

This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ Nitinol Stent System compared to balloon angioplasty. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study.

Objective of the study is: Performance of the Cordis S.M.A.R.T.™ (CONTROL™) Nitinol Stent System for the treatment of superficial femoral artery (SFA) long de novo or restenotic lesions (≥ 70% stenosis or occlusions) in comparison with balloon angioplasty as determined by Binary Restenosis (≥50% restenosis based on a peak systolic velocity ratio ≥ 2.5) at one year as demonstrated by Duplex sonography.

Condition or disease Intervention/treatment Phase
Superficial Femoral Artery Occlusions Device: stent Device: balloon Phase 4

Detailed Description:

The study population will consist of 120 symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, de novo or restenotic occlusions (5 - 22 cm) on diagnostic imaging. The occlusions must not extend beyond the proximal popliteal artery. For the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. At least one calf vessel must be patent. Reference vessel diameter must be >= 4.0 to <= 6.0 mm.

Trial participants who meet all entry criteria, will be randomized to the SMART™ Nitinol Stent or balloon angioplasty.

Patients will be followed for 12 months after the procedure. Study examinations will be done at screening, procedure time, discharge, 1, 6 and 12 months after the study procedure.

This study will be conducted as an investigator initiated multicenter study with 6 study centers in Switzerland. Principal investigators will be Prof. Amann, PD Dr. med T. Pfammatter (University Hospital Zürich) and Prof. I. Baumgartner, Prof. J. Triller (University Hospital Bern).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Prospective, Randomized, Two-Arm Clinical Investigation of the Cordis SMARTTM Nitinol Self Expandable Stent Versus Balloon Angioplasty Only for the Treatment of Superficial Femoral Artery Occlusions.
Study Start Date : December 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: 1
Cordis SMART™ nitinol self expandable stent
Device: stent
Cordis SMART™ Nitinol Stent System

Active Comparator: 2
Device: balloon
balloon angioplasty

Primary Outcome Measures :
  1. Binary restenosis by Duplex Ultrasound. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Technical success defined as a successful access and deployment of the device with recanalization. [ Time Frame: at the time of deployment ]
  2. Procedural complications. [ Time Frame: up to the moment the catheter sheath introducer has been removed ]
  3. Procedural success as defined by successful recanalization, without the occurence of a Serious Adverse Event (SAE). [ Time Frame: up to the catheter sheath introducer has been removed ]
  4. Occurrence of Adverse events (AE) and Serious Adverse Events (SAE) in-hospital. [ Time Frame: 1, 6 and 12 months ]
  5. Ankle Brachial Index (ABI). [ Time Frame: discharge, 1, 6 and 12 months ]
  6. Restenosis measured by Duplex sonography. [ Time Frame: 1, 6 and 12 months ]
  7. Target Lesion revascularisation (TLR). [ Time Frame: 1 year ]
  8. Target Vessel revascularisation (TVR). [ Time Frame: 1 year ]
  9. Target Limb revascularisation. [ Time Frame: 1 year ]
  10. The number of revascularisations in both limbs. [ Time Frame: 1 year ]
  11. Clinical categorization of chronic limb ischemia by means of the Rutherford classification. [ Time Frame: 1, 6 and 12 months ]
  12. Pain free and absolute walking distance (treadmill testing) as compared to baseline testing. [ Time Frame: 1 and 12 months post index procedure ]
  13. Amputation of the index limb. [ Time Frame: 1 year ]
  14. Cardiovascular events (ACS, TIA, stroke, vascular death). [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 3 months;
  2. One de-novo or restenotic SFA with an occluded length > 5 to < 22 cm;
  3. Patent popliteal artery on the index side (without > 50% stenotic (re) stenotic lesions) and at least single vessel infrapopliteal runoff (without > 50% stenotic (re) stenotic lesions). However, balloon angioplasty to further improve the blood flow is allowed at the index procedure.

Exclusion Criteria:

  1. Revascularization involving the same limb 30 days prior to the index procedure or a planned revascularization within 30 days after the index procedure;
  2. Patients having severe stenoses or total occlusions of the iliac artery on the same side must be excluded. However, intervention to restore adequate blood flow during the index procedure (prior to the treatment of the target lesion) is allowed;
  3. Requiring stent placement in the popliteal artery. For the purpose of this protocol all lesions are to be located at least three centimetres proximal to the superior edge of the patella.

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): NCT00309595

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Univeristy Hospital Bern
Bern, Switzerland, CH-3010
University Hospital Zurich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Cordis Corporation
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Principal Investigator: Iris Baumgartner, MD Leitende Aerztin & Leiterin Vaskuläre Forschung - University Hospital Bern
Principal Investigator: Beatrice Amann, MD Leitende Ärztin Angiologie - University Hospital Zurich

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Responsible Party: Dr. Hans-Peter Stoll - Medical Affairs Director, Cordis Identifier: NCT00309595    
Other Study ID Numbers: EE04-03
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: June 12, 2009
Last Verified: June 2009
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases