Please select the eligibility criteria that correspond to the clinical trial below.
Title: Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA Study
Brief Summary: The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.


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:

* Patient signed informed consent for data release
* Patient eligible for percutaneous coronary intervention (PCI)
* De novo and re-stenosed coronary artery lesions
* Patient is geographically stable and willing to participate at all follow up assessments
* Patient is \> 18 years of age

Exclusion Criteria:

* Patient receives more than one stent, which is not a PRO-Kinetic ENERGY stent within the same vessel
* Patient has a known allergy against aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI
* Patient presents with ISR (in-stent restenosis)
D: 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

Answer: D