This study is a comparison of two different ways to treat blockage in the artery of the thigh. The first is an older way with incisions in the groin and just above the knee. A plastic tube is then inserted to make a bypass from the groin to the knee. The second treatment offered is through a needle hole in the groin. A thin plastic tube covering a metal stent is inserted into the artery and released to bypass the blockage from inside the artery. No incisions are needed. Patients are enrolled and then selected for one treatment method or another by chance. The patients will be followed for two years to see how the two different treatment methods work compared to each other.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
Surgical placement of a prosthetic graft in the thigh from the groin to the knee
Placement of an ePTFE covered stent graft within the superficial femoral artery in the thigh through a needle hole percutaneously
Baylor University Medical Center
Dallas, Texas, United States
Primary artery/graft patency
Time frame: 24 months
Limb Salvage
Time frame: 24 months
Improvement in symptoms of lower extremity Ischemia
Time frame: 24 Months
Secondary artery/graft patency
Time frame: 24 months
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