The Study to Compare SMART Nitinol Stent and Balloon Angioplasty (SIT-UP)
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.
Superficial Femoral Artery Occlusions
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.|
- Binary restenosis by Duplex Ultrasound. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Technical success defined as a successful access and deployment of the device with recanalization. [ Time Frame: at the time of deployment ] [ Designated as safety issue: No ]
- Procedural complications. [ Time Frame: up to the moment the catheter sheath introducer has been removed ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Occurrence of Adverse events (AE) and Serious Adverse Events (SAE) in-hospital. [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: Yes ]
- Ankle Brachial Index (ABI). [ Time Frame: discharge, 1, 6 and 12 months ] [ Designated as safety issue: Yes ]
- Restenosis measured by Duplex sonography. [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: Yes ]
- Target Lesion revascularisation (TLR). [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Target Vessel revascularisation (TVR). [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Target Limb revascularisation. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- The number of revascularisations in both limbs. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Clinical categorization of chronic limb ischemia by means of the Rutherford classification. [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: Yes ]
- Pain free and absolute walking distance (treadmill testing) as compared to baseline testing. [ Time Frame: 1 and 12 months post index procedure ] [ Designated as safety issue: Yes ]
- Amputation of the index limb. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Cardiovascular events (ACS, TIA, stroke, vascular death). [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2005|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Cordis SMART™ nitinol self expandable stent
Cordis SMART™ Nitinol Stent System
Active Comparator: 2
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309595
|Univeristy Hospital Bern|
|Bern, Switzerland, CH-3010|
|University Hospital Zurich|
|Zurich, Switzerland, CH-8091|
|Principal Investigator:||Iris Baumgartner, MD||Leitende Aerztin & Leiterin Vaskuläre Forschung - University Hospital Bern|
|Principal Investigator:||Beatrice Amann, MD||Leitende Ärztin Angiologie - University Hospital Zurich|