Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Study Comparing the Edwards Self-ExpandIng LifeStent Versus Angioplasty-alone In LEsions INvolving The SFA and/or Proximal Popliteal Arter
Brief Summary: The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral artery (SFA) disease by reducing the re-intervention rate as compared to percutaneous transluminal angioplasty (PTA) alone


Options:
A: Inclusion Criteria:

* Patient has signed and dated the informed consent.
* Patient has up to 2 documented stenotic or occluded atherosclerotic lesions (up ro 14 cm long) of the above-the-knee femoropopliteal artery, up to one in each limb, that meet all of the inclusion criteria and none of the exclusion criteria.
* Patient has a de novo or restenotic lesion(s) with \>50% stenosis documented angiographically and no prior stent in the target lesion.
* Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.
* Patient has a resting Ankle Brachial Index (ABI) \<0.9 or an abnormal exercise ABI if resting ABI is normal. Patient with incompressible arteries (ABI \>1.2) must have a Toe Brachial Index (TBI) \<0.8.
* Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 months, 12 months, and at 2, 3, 4, and 5 years.
* Patient agrees to return for x-rays at 6 and 12 months.
* Patient agrees to return for angiography at 12 months.
* Patient agrees to be contacted by telephone at 1, 3, 9, and 18 months to assess clinical status.

Exclusion Criteria:

* Patient is pregnant or breast-feeding.
* Patient is simultaneously participating in another investigational drug or device study.
* Patient has significant stenosis or occlusion of inflow tract not successfully treated before this procedure.
* Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
* Patient has had previous stenting of target vessel.
* Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
* Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol and, in the opinion of the investigator, cannot be adequately premedicated.
* Patient lacks at least one patent vessel of runoff with \<50% stenosis throughout its course.
* Patient has untreated angiographically-evident thrombus in the target lesion.

\[Additional criteria may apply.\]
B: Inclusion Criteria:

* Written informed consent approved by the IRB.
* ≥ 18 years old.
* Lifestyle-limiting claudication defined as: Rutherford Cat. 1-3.
* Target lesion(s) is de-novo or restenotic and located within the native SFA and/or proximal popliteal artery
* Angiographic evidence of ≥ 50% stenosis or occlusion
* Target RVD is ≥ 4.0 mm and ≤ 7.0 mm
* Target total length of the lesion or series of lesions is ≤ 150 mm.
* Angiographic evidence of at least one vessel runoff to the foot.

Exclusion Criteria:

* Unable to conform to the study protocol procedures and visits.
* Lifestyle-limiting claudication/CLI (Rutherford Cat. 4-6)
* Patients who are pregnant or planning to become pregnant during the clinical investigation
* Contraindication to study related medications, Ni, Ti, Ta, or other media that is not amenable to pretreatment.
* History of bleeding diatheses or coagulopathy.
* Concomitant renal failure with a creatinine of \> 2.0 mg/dL.
* Concomitant hepatic insufficiency, thrombophlebitis, uremia, SLE, or DVT at the time of the study procedure.
* Receiving dialysis or immunosuppressive therapy.
* Suffered a hemorrhagic stroke ≤ 6 mo prior to the study procedure.
* Prior peripheral vascular bypass surgery involving the target limb.
* Target vessel has been previously stented.
* Target lesion(s) received angioplasty intervention ≤ 6 mo. prior
* Any non-iliac percutaneous intervention(s) \< 7 days prior.
* Currently participating in an investigational drug/device study.
* Limited life expectancy of less than two years.
* Extensive PVD that precludes safe insertion of an sheath.
* Target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s).
* Unresolved thrombus within the target vessel.
* Poor inflow which would not support a vascular bypass graft.
* Diagnosed with septicemia at the time of the study procedure.
* Additional percutaneous interventional procedures (cardiac/peripheral) planned ≤ 30 days following procedure.
C: Inclusion Criteria:

* Age ≥ 18 years old;
* Subject is a candidate for percutaneous intervention for peripheral arterial disease in the legs;
* Subject is willing and able to give informed consent;
* Documented symptomatic atherosclerotic peripheral arterial disease Rutherford Classification 2-5;
* Reference vessel lumen proximal to target lesion ≥ 2.5 mm and ≤ 7.0 mm in diameter by visual estimation;
* Subject has de novo target lesion(s) with stenosis \>70% by visual estimation distal to the profunda femoral artery. No more than 2 lesions may be treated with the Pantheris device;
* Target lesion length ≤ 15 cm (may be two tandem lesions that do not exceed 15cm in total length);
* Subject is capable of meeting requirements and be present at the follow-up clinic visits at 30 days and 6 months;
* At least one patent tibial run-off vessel at baseline.

Inclusion Criteria for the 24-month follow up:

* Completed the 6-month follow-up visit
* Re-consented prior to the 24-month follow-up visit

Exclusion Criteria:

* Subject is pregnant or breast feeding;
* Rutherford Class 0 to 1 (asymptomatic and mild claudication);
* Rutherford Class 6 (critical limb ischemia);
* Moderate to severe calcification of the target lesion;
* Acute ischemia and/or acute thrombosis of the Superficial Femoral Artery (SFA)-Popliteal segment;
* In-stent restenosis within the target lesion;
* Target lesion with any type of stent or graft;
* Target lesion in the iliac artery;
* Target lesion stenosis \<70%;
* Subjects with significant (≥70%) occlusive lesions proximal to the target lesion not successfully treated during the index procedure (upstream disease) and prior to treatment of the target lesion;
* Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure;
* Planned endovascular or surgical procedure 30 days after the index procedure;
* Lesion in the contralateral limb requiring intervention during the index procedure or within 30 days of the index procedure;
* Subjects with active systemic infections whether they are being currently treated or not;
* Subjects on chronic hemodialysis or creatinine level \>2.0mg/dL;
* Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months;
* Evidence or history of aneurysmal target vessel within the past 2 months;
* History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days;
* Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated;
* Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated;
* History of heparin-induced thrombocytopenia (HIT);
* Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/mm2, known coagulopathy, or International Normalized Ratio (INR) \>1.5;
* Any thrombolytic therapy within 2 weeks of the index procedure;
* Any clinical and/or angiographic complication attributed to the use of another device prior to the insertion of the study device into the subject;
* Subjects or their legal guardians who have not or will not sign the Informed Consent;
* Subjects who are unwilling or unable to comply with the follow-up study requirements;
* Participation in any study of an investigational device, medication, biologic or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of the study.
D: Inclusion Criteria:

* Patients presenting with Fontaine IIB, III, IV ischemia
* Long (\>10 cm) occlusion of the superficial femoral artery, with patent popliteal artery and at least 1 patent crural vessel
* Atherosclerotic disease

Exclusion Criteria:

* Previous operations on the superficial femoral artery
* Radiation therapy groin/leg region
* Diameter superficial femoral artery \< 4 mm
* Contrast allergy

Answer: B