The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
85
Angioplasty with Drug eluting balloon after pre dilatation
Nitinol stent deployment
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
Primary patency
Evaluations will be conducted after 3, 6 and 12 months of the procedure. The ultrasonographic evaluation of the degree of stenosis will use the Systolic Velocity Index (division of the velocity of flow at the point of greatest stenosis by the velocity of flow in normal prior segment). Rates higher than 2.4 indicate stenosis greater than 50%
Time frame: 12 months
Rutherford classification
Change in classification from Rutherford evaluated in 3, 6 and 12 months.
Time frame: 12 months
Ankle braquial Index
Change in the Ankle braquial Index evaluated in 3, 6 and 12 months
Time frame: 12 months
Target Lesion Revascularization
Target Lesion Revascularization rate evaluated in 3, 6 and 12 months
Time frame: 12 months
Stent fracture
Stent fracture rate evaluated in 3, 6 and 12 months
Time frame: 12 months
Amputation
Major amputation defined as amputation that requires prosthesis
Time frame: 12 months
Acute myocardial infarct
Acute myocardial infarct rate evaluated in 3, 6 and 12 months
Time frame: 12 months
Death
Death rate evaluated in 3, 6 and 12 months
Time frame: 12 months
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