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).
|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|