Back to resultsThe Study to Compare SMART Nitinol Stent and Balloon Angioplasty (SIT-UP)
Primary Purpose
Superficial Femoral Artery Occlusions
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
stent
balloon
Sponsored by
About this trial
This is an interventional treatment trial for Superficial Femoral Artery Occlusions
Eligibility Criteria
Inclusion Criteria: 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; One de-novo or restenotic SFA with an occluded length > 5 to < 22 cm; 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: Revascularization involving the same limb 30 days prior to the index procedure or a planned revascularization within 30 days after the index procedure; 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; 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.
Sites / Locations
- Univeristy Hospital Bern
- University Hospital Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Cordis SMART™ nitinol self expandable stent
balloon
Outcomes
Primary Outcome Measures
Binary restenosis by Duplex Ultrasound.
Secondary Outcome Measures
Technical success defined as a successful access and deployment of the device with recanalization.
Procedural complications.
Procedural success as defined by successful recanalization, without the occurence of a Serious Adverse Event (SAE).
Occurrence of Adverse events (AE) and Serious Adverse Events (SAE) in-hospital.
Ankle Brachial Index (ABI).
Restenosis measured by Duplex sonography.
Target Lesion revascularisation (TLR).
Target Vessel revascularisation (TVR).
Target Limb revascularisation.
The number of revascularisations in both limbs.
Clinical categorization of chronic limb ischemia by means of the Rutherford classification.
Pain free and absolute walking distance (treadmill testing) as compared to baseline testing.
Amputation of the index limb.
Cardiovascular events (ACS, TIA, stroke, vascular death).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00309595
Brief Title
The Study to Compare SMART Nitinol Stent and Balloon Angioplasty
Acronym
SIT-UP
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 Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Femoral Artery Occlusions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cordis SMART™ nitinol self expandable stent
Arm Title
2
Arm Type
Active Comparator
Arm Description
balloon
Intervention Type
Device
Intervention Name(s)
stent
Intervention Description
Cordis SMART™ Nitinol Stent System
Intervention Type
Device
Intervention Name(s)
balloon
Intervention Description
balloon angioplasty
Primary Outcome Measure Information:
Title
Binary restenosis by Duplex Ultrasound.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Technical success defined as a successful access and deployment of the device with recanalization.
Time Frame
at the time of deployment
Title
Procedural complications.
Time Frame
up to the moment the catheter sheath introducer has been removed
Title
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
Title
Occurrence of Adverse events (AE) and Serious Adverse Events (SAE) in-hospital.
Time Frame
1, 6 and 12 months
Title
Ankle Brachial Index (ABI).
Time Frame
discharge, 1, 6 and 12 months
Title
Restenosis measured by Duplex sonography.
Time Frame
1, 6 and 12 months
Title
Target Lesion revascularisation (TLR).
Time Frame
1 year
Title
Target Vessel revascularisation (TVR).
Time Frame
1 year
Title
Target Limb revascularisation.
Time Frame
1 year
Title
The number of revascularisations in both limbs.
Time Frame
1 year
Title
Clinical categorization of chronic limb ischemia by means of the Rutherford classification.
Time Frame
1, 6 and 12 months
Title
Pain free and absolute walking distance (treadmill testing) as compared to baseline testing.
Time Frame
1 and 12 months post index procedure
Title
Amputation of the index limb.
Time Frame
1 year
Title
Cardiovascular events (ACS, TIA, stroke, vascular death).
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
One de-novo or restenotic SFA with an occluded length > 5 to < 22 cm;
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:
Revascularization involving the same limb 30 days prior to the index procedure or a planned revascularization within 30 days after the index procedure;
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;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Baumgartner, MD
Organizational Affiliation
Leitende Aerztin & Leiterin Vaskuläre Forschung - University Hospital Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Beatrice Amann, MD
Organizational Affiliation
Leitende Ärztin Angiologie - University Hospital Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy Hospital Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
12. IPD Sharing Statement
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The Study to Compare SMART Nitinol Stent and Balloon Angioplasty
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