The objective of this prospective, randomized,controlled and multicenter trial is, to compare recurrent-restenosis rates in the balloon expandable VISIO-PRO stent arm and the selfexpandable PROTEGE GPS stent arm 12 month after treatment of stenosis or occlusions of common and external iliac artery disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
660
Visi-Pro balloon expandable stent vs. PROTEGE GPS selfexpanding nitinol stent to treat stenosis or occlusion of common and external iliac artery disease
Medical Care Center Prof. Mathey, Prof. Schofer
Hamburg, Hamburg, Germany
Duplex-ultrasound determined recurrent restenosis after 12 month
Duplex-ultrasound definition: = recurrent stenosis ≥ 70% in relation to vessel diameter or PSV \>3.4 per duplex ultrasound
Time frame: 12 month
Clinical improvement of walking distance and improvement of at least 1 Rutherford category
Clinical improvement of walking distance and improvement of at least 1 Rutherford category
Time frame: 12 and 24 month
Improvement of ABI of at least o.1 points in treated leg after 6 and 12 month (AHA Guidlines)
Time frame: 6 and 12 month
Clinically driven target lesion revascularization (TLR and TVR) at 6 and 12 month
TLR = Target Lesion Revascularisation TVR = Target Vessel Revascularisation
Time frame: at 6 and 12 month
Recurrent stenosis >= 70%within the stent at 6 and 12 month
Time frame: at 6 and 12 month
Clinical and hemodynamic parameters (walking distance, ABI, Rutherford category) at 1, 6 and 12 month
Time frame: at 1, 6 and 12 month
Primary angiographic success rate (<30% residual stenosis)
Time frame: Procedure
Major adverse vascular events plus death rate
Major adverse vascular events plus death rate
Time frame: 24 month
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