The primary objective of this study is to compare the performance of the CYPHER SELECTTM + Sirolimus-eluting Balloon-expandable Coronary and Infrapopliteal Stent over balloon angioplasty in de novo and restenotic native below the knee tibioperoneal, anterior and/or posterior tibial and/or peroneal arterial lesions in a prospective, multicenter, randomized clinical study.
This is a multicenter, prospective, randomized study to be conducted in 18 centers in Europe. A total of 200 subjects will be entered into the study and will be randomized on a 1:1 basis to either balloon angioplasty or the CYPHER SELECTTM + Coronary and Infrapopliteal Stent for infrapopliteal use in subjects with symptomatic peripheral artery disease (Rutherford 3, 4, or 5). All subjects will undergo a repeat angiography at 12 months to assess the primary endpoint of In-Segment Binary Restenosis. Follow-up visits are scheduled at 6 weeks, 6 and 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
balloon angioplasty
Cypher Select+ Coronary or Infrapopliteal Stent
Universität Leipzig - Herzzentrum
Leipzig, Germany
In-Segment Binary Restenosis
Time frame: 12-months
Mean percent diameter stenosis (%DS) and minimal lumen diameter (MLD) measured by quantitative angiography post-procedure.
Time frame: 12 months
In-segment late loss measured by quantitative angiography.
Time frame: 12 months
In-stent late loss measured by quantitative angiography.
Time frame: 12 months
Patency defined as detectable flow measured by Duplex Ultrasound.
Time frame: 6 weeks, 6 and 12 months
Target Lesion Revascularization (TLR), and Target Vessel Revascularization (TVR).
Time frame: 6 weeks, 6 and 12 months;
Assessment for stent fractures by X-Ray.
Time frame: 12 months
Device Success defined as achievement of a final residual diameter stenosis of <30% (by QA), using the assigned device only.
Time frame: post procedure
Lesion Success defined as achievement of <50% (by QA) residual stenosis using any percutaneous method.
Time frame: post procedure
Procedural Success defined as achievement of final diameter stenosis of <50% (by QA) using any percutaneous method, without the occurrence of an SAE up to catheter sheath removal or subject leaving the cath lab, whichever is earlier.
Time frame: post procedure
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Procedural Complications defined as any adverse event from the time of arterial punction up to the moment of catheter sheath removal or subject leaving the cath lab, whichever is earlier.
Time frame: post procedure
Serious Adverse Events
Time frame: At procedure up to discharge, 6 weeks, 6 and 12 months
Rutherford classification
Time frame: At screening, 6 weeks, 6 and 12 months
Ankle Brachial Index measured
Time frame: At screening, 6 weeks, 6 and 12 months
Amputation
Time frame: 6 weeks, 6 and 12 months
Quality of Life assessment.
Time frame: 6 weeks, 6 and 12 months
Wound status of index limb (if applicable) due to CLI measured by digital photography, depth/length/width measurements, infection and wound closure status.
Time frame: screening, 6 weeks, 6 and 12 months