Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
W.L.Gore & Associates
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient has a previously implanted (\> 30 days) non-covered stent(s) located in the SFA
Patient has life-style limiting claudication, resting leg pain or minor tissue loss (Rutherford Category 2 - 5)
Patient demonstrates an Ankle Brachial Index (ABI) \<=0.9. If ABI \>0.9 or not measurable, patient is eligible for study if Toe Brachial Index is \<=0.5
Patient has \>=50% in-stent restenosis and / or an occlusion in a previously implanted (\>30 days) non-covered stent(s) located in the superficial femoral artery defined as beginning at least 1cm below the origin of the profunda femoris artery and ending at least 1cm above the intercondylar notch.
Patient has a maximum total lesion length of 270mm, consisting of in-stent and adjacent occlusive disease
Patient has a reference vessel diameter between 4.0 and 6.5mm
Patient has at least one patent infrapopliteal runoff vessel (\<50% stenosis) not requiring reintervention
You may not be if
Patient has a known allergy to stent graft components (nickel-titanium or expanded-polytetrafluoroethylene)
Patient has a known intolerance to anticoagulation or antiplatelet therapy
Patient has known coagulation disorder, including hypercoagulability.
Patient has major distal amputation (above the transmetatarsal)
Patient has any previous surgery in the target vessel
Patient has had previous target vessel in-stent restenosis treated by relining with another stent
Patient has untreated flow-limiting aortoiliac stenotic disease
