Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Trial of IN.PACT Admiral(TM) Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease
Brief Summary: The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral® drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug coated) PTA balloons. The IN.PACT Admiral, besides the mechanical dilatation effect typical of all PTA balloons, releases a drug (paclitaxel) from the balloon surface into the vessel walls. This drug absorption is intended to limit the chances and the entity of artery re-narrowing over time.


Options:
A: Inclusion Criteria:

* Rutherford stage 1, 2, 3, 4 oder 5
* Occlusion or Stenosis of Superficial femoral and/or popliteal artery
* Successful guide wire passage of the lesion
* Patient suitable of vascular surgery in case of complication
* Written consent
* Patient is willing to take part in follow up examinations within the study

Exclusion Criteria:

* Acute ischemia
* Distal run off less than one vessel
* Pregnancy
* Hyperthyroidism
* Thrombocytes \<100.000/mm3 or \>700.000/mm3, Leucocytes \<3.000/mm3
* Life expectancy less than two years
* Patients not willing to enter the study
B: General Inclusion Criteria:

* Age ≥18 years and ≤85 years
* Patient or patient's legal representative is informed of the nature of the study, agrees to participate and has signed an EC approved consent form

Angiographic Inclusion Criteria:

- Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee)

General Exclusion Criteria:

* Patient unwilling or unlikely to comply with follow-up schedule
* Stroke or STEMI within 3 months prior enrolment

Angiographic Exclusion Criteria:

- Acute or sub-acute thrombus in the target vessel
C: Inclusion Criteria:

* age\>18 years
* intermittent claudication(Fontane III or IV)
* angiographic stenosis\>50% or occlusion of superficial femoral-popliteal artery\>40mm
* at least one below-knee vessel to the ankle

Exclusion Criteria:

* allergy to Paclitaxel
* contraindication for combined antiplatelet treatment
* life expectancy \<1 year
* hypersensitivity or contraindication to one of the study drugs
* lack of consent
D: 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

Answer: B