Please select the eligibility criteria that correspond to the clinical trial below.
Title: Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries (Thunder - Trial)
Brief Summary: The Thunder Trail is a randomized , double-blinded, placebo controlled German multi-centre study on the efficacy of local paclitaxel for prevention of restenosis in the superficial and popliteal artery.


Options:
A: 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
B: Inclusion Criteria:

* Subject must meet all of the following general inclusion criteria.

  1. Has a Rutherford Clinical Category Score of 1 - 5.
  2. Is willing and capable of complying with all follow-up evaluations at the specified times.
  3. Is ≥ 18 years old.
  4. Provides written informed consent prior to study specific procedures.

Exclusion Criteria:

* The subject must not meet any of the following general exclusion criteria.

  1. Has contraindications listed in any study device IFUs.
  2. Has a contraindication or known untreated allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used.
  3. Has a hypersensitivity to contrast material that cannot be adequately pretreated.
  4. Has known hypersensitivity to treatment device materials including Paclitaxel. Has known uncontrollable hypercoagulable condition, or refuses blood transfusion.

  6. Has life expectancy of less than 12 months. 7. Is pregnant, of childbearing potential not taking adequate contraceptives, or nursing.

  8. Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure.

  9. Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.

  10. Is currently participating in an investigational drug or another device study that may clinically interfere with the study outcomes.

  11. Any co-morbid condition that in the judgment of the physician precludes safe percutaneous intervention.

  12. Has had a previous peripheral bypass affecting the target vessel. 13. Has chronic renal insufficiency with creatinine \> 2.5 mg/L (except patients under chronic renal replacement therapy).

  14. Is unable or unwilling to receive dual anti-platelet therapy. 15. Equipment is unavailable to fulfill study treatments.
C: 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
D: 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.

\[Additional criteria may apply.\]

Answer: A