Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic Endovascular
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts), or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries suitable for primary stenting.
2. Has a Rutherford Clinical Category Score of 2, 3 or 4.
3. Is willing to comply with all follow-up evaluations at the specified times.
4. Is ≥ to18 years old.
5. Provides written informed consent prior to enrollment in the study.
1. Target lesion(s) located within the native SFA/proximal popliteal: distal point at least 3 cm above the cortical margin of the femur and proximal point at least 1 cm below the origin of the profunda femoralis measured by straight posteroanterior (PA) view for distal lesions, ipsilateral oblique view for proximal lesions.
2. Evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s).
3. Target lesion(s) total length is ≥ 4 cm and ≤ 18 cm.
4. Target vessel diameter is ≥ 4.5 mm and ≤ 7.5 mm.
5. There is evidence of at least one runoff vessel to the ankle/foot of the limb to be treated that does not also require treatment for significant (\> 50% stenosis or occlusion) stenosis during the index procedure.
You may not be if
1. Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.
2. Has a contraindication or known allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, contrast media or any other drug used in study according to the protocol.
3. Has known hypersensitivity to nickel-titanium.
4. Has bleeding diathesis, coagulopathy, known hypercoagulable condition, or refuses blood transfusion.
5. Female currently breastfeeding, pregnant, or of childbearing potential not using adequate contraceptive measures.
6. Has life expectancy of less than 1 year.
7. Has planned use of thrombectomy, atherectomy, brachytherapy or laser devices during procedure.
8. Has previously been enrolled in the DURABILITY PAS study.
9. Has received endovascular treatment of target lesion by percutaneous transluminal angioplasty or any other means of previous endovascular treatment (e.g. cutting balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices) within six months of the index procedure.
10. Has any planned surgical intervention or endovascular procedure 14 days before or 30 days after the index procedure.
11. Is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
12. Has any co-morbid condition that precludes endovascular treatment.
1. Exchangeable guidewire cannot cross the target lesion and/or re-enter true vessel lumen distal to lesion(s).
2. Presence of significant (\> 50% stenosis or occlusion) ipsilateral common femoral stenosis.
3. Aneurysmal target vessel.
4. Presence of an acute intraluminal thrombus at the proposed lesion site.
5. Perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to start of PTA procedure.
6. Focal popliteal disease in the absence of femoral disease.
