Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Catheter vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries With and Without Stenting.
Brief Summary: The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.


Options:
A: Inclusion Criteria:

Clinical Criteria

* Male or non-pregnant female ≥18 years of age.
* Rutherford Clinical Category 2-5
* Patient is willing to provide informed consent and comply with the required follow up visits, testing schedule, and medication regimen Angiographic Criteria
* A single de novo or restenotic atherosclerotic lesion \>70% in the SFA or popliteal artery that is ≥4 cm and ≤15 cm in total length.
* Reference vessel diameter ≥4 mm and ≤ 6mm
* Successful wire crossing of lesion
* A patent inflow artery free from significant lesion (\>50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow artery lesions)

Exclusion Criteria:

* Pregnant or planning on becoming pregnant in \< 2yrs
* Live expectancy of \<2 years
* Patient actively participating in another investigational device or drug study
* History of hemorrhagic stroke within 3 months
* Previous or planned surgical or interventional procedure within 30 days of index procedure
* Chronic renal insufficiency with creatinine \>2.5 mg/L
* Prior surgery of the target lesion
* Inability to take required study medications
* Anticipated use of IIb/IIIa inhibitor prior to randomization
* Lesion length is \<4 cm or \>15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured
* Known inadequate distal outflow
* Significant inflow disease
* Acute or sub-acute thrombus in target vessel
* Severe lesion calcification
* Acute vessel occlusion or sudden symptom onset
* Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.)
* Prior participation in the current study
B: Inclusion Criteria:

* Age: \> or equal to 18 years and \< or equal to 85 years
* Documented ischemia with Rutherford classification 2, 3, or 4
* Target lesion in the SFA and/or PPA
* Angiographic evidence that target lesion consists of a single de novo or non-stented restenotic lesion or is a combination lesion that meets the following criteria:

  1. 70 - 99% occlusion by visual estimate with lesion length \> or equal to 4 cm and \< or equal to 18 cm
  2. 100% occlusion by visual estimate with lesion length \< or equal to 10 cm
  3. Combination lesions must have a total lesion length of \> or equal to 4 cm and \< or equal to 18 cm with an occluded segment that is \< or equal to 10 cm (by visual estimate)
* Target vessel diameter \> or equal to 4 mm and \< or equal to 7 mm
* Angiographic evidence of adequate distal run-off to the ankle
* Able to walk without assistive devices

Exclusion Criteria:

* Stroke or heart attack within 3 months prior to enrollment
* Enrolled in another investigational drug, device or biologic study
* Any surgical procedure or intervention performed within 30 days prior to or post index procedure
* SFA or PPA disease in the opposite leg that requires treatment at the index procedure
* Failure to successfully cross the target lesion
* Angiographic evidence of severe calcification
* Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices)
* Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
* Chronic kidney disease
C: Inclusion Criteria:

* stenosis of the above-the-knee femoropopliteal artery
* appropriate size and location of the lesion

Exclusion Criteria:

* pregnant or breast feeding
* failure or inability to give informed consent
* simultaneously participating in another drug or device study
D: Inclusion Criteria:

* Adults
* Chronic Occlusions and stenosis (history at least 6 weeks) ≥70 % diameter Stenosis \> 2cm in the arteria femoralis superficialis or arteria poplitea
* Various criteria assuring ethical issues and follow up

Exclusion Criteria:

* Conditions requiring different treatment or raising serious safety concern regarding the procedure or the required medication.
* Pregnancy can not be excluded
* Doubts in the willingness or capability of the patient to allow 6 months follow up

Answer: A