Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Randomized, Multicenter Comparison of Balloon Angioplasty and the Cypher Selecttm + Coronary and Infrapopliteal Stent in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease
Brief Summary: The primary objective of this study is to compare the performance of the CYPHER SELECTTM + Sirolimus-eluting Balloon-expandable Coronary and Infrapopliteal Stent over balloon angioplasty in de novo and restenotic native below the knee tibioperoneal, anterior and/or posterior tibial and/or peroneal arterial lesions in a prospective, multicenter, randomized clinical study.


Options:
A: Inclusion Criteria:

* Subject must be \>= 18 and \<= 85 years old;
* Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation;
* Clinical diagnosis of symptomatic critical limb ischemia as defined by Rutherford 3, 4, or 5;
* Single treatment of de novo or restenotic (after PTA only) lesion(s) in the tibioperoneal trunk, anterior and/or posterior tibial and/or peroneal artery;
* A maximum of 2 vessels in 1 limb may be treated in the study, each vessel for only 1 target lesion, resulting in at single risk target lesion(s); In case 1 target lesion is located in the Tibioperoneal trunk, the 2nd target lesion (if applicable) can only be located in the anterior tibial artery; Additional non-target lesion(s) in remaining non-target vessel(s) can be treated at the physician's discretion by means of balloon dilation (± bail-out stenting);
* The sum of the total length of both target lesions can be maximum 120 mm;
* In total a maximum of 4 stents may be implanted to fully cover the maximum of 2 target lesions per subject;
* Target vessel is \>= 2.5 and \<= 3.5 mm in diameter (visual estimate);
* Target lesion stenosis is \>70% diameter stenosis (visual estimate);
* Guidewire must be across the first (if applicable) target lesion and located intraluminally within the distal vessel before study randomization;
* Willing to comply with the specified follow-up evaluation;
* Written informed consent prior to any study procedures.

Exclusion Criteria:

* Significant (\>50%) stenoses distal to the target lesion that might require revascularization, or impede runoff;
* Angiographic evidence of thrombus within target vessel;
* Thrombolysis within 72 hours prior to the index procedure;
* Lesions not suitable for stenting;
* Lesions (defined as stenosis \> 75%) in the common or external iliac, common or superficial femoral and popliteal artery. However, intervention in TASC A and B lesions (max. 15cm) to restore adequate blood flow, in the same index procedure is allowed. This intervention must be prior to the treatment of the study lesion(s) and successful;
* Lesions located at the bifurcation requiring treatment of both branches (1 in main branch and 1 in side branch);
* Required stent placement across or within 1 cm of the knee joint; in an artery subject to external compression, or in an artery directly subject to movement of the ankle or knee joint;
* Prior stent(s) within the target vessel(s);
* Aneurysm in the SFA or popliteal artery;
* Requiring popliteal arterial access;
* Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy;
* Recent MI or stroke \< 30 days prior to the index procedure;
* Coronary intervention \< 30 days prior to the index procedure;
* Life expectancy less than 12 months;
* Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb;
* Impaired renal function (creatinine \> 2.5 mg/dl);
* Known or suspected allergies or contraindications to aspirin, clopidogrel bisulfate (PlavixÒ) and ticlopidine (Ticlidâ), heparin, stainless steel or contrast agent;
* The subject is currently taking Coumarin / Warfarin which, in the opinion of the investigator, interferes with the subject's participation in the study;
* Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study;
* The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
B: Inclusion Criteria:

* Clinical diagnosis of peripheral arterial occlusive disease as defined by Rutherford 2-5
* De-novo stenosis of \> 70% diameter stenosis in the tibioperoneal trunc, anterior and/or posterior tibial and/or peroneal artery
* Target lesion length of ≤ 45 mm

Exclusion Criteria:

* Coagulation disorder
* Known allergy to contrast medium
* Contraindications to antiplatelet therapy or heparin
C: Inclusion Criteria:

1. Age \> 50 years
2. Patient has signed the patient informed consent.
3. Patient is willing to adhere to the follow up time points and to follow the requirements during the study
4. Patient has symptomatic critical limb ischemia or severe intermittent claudication classified as Rutherford category 3, 4 or 5.
5. Stenotic (\> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries below the radiographic level of the knee joint and above the level of the ankle (includes the peroneotibial trunk, anterior tibial artery, posterior tibial artery and peroneal artery, excludes the popliteal artery), as determined by pre-procedure intra-arterial DSA (preferred) or conventional angiography.
6. Target (study) lesion to be treated is a de novo lesion (lesion ≤ 190 mm length). NOTE: Multiple or diffused lesion treatment is allowed as long as total lesion length ≤ 190 mm)
7. Reference vessel diameter is between 2.5 and 4.0 mm.
8. Target vessel: It must be possible to follow the vessel run-off to the foot and/or the wound area. NOTE: Patients with incomplete or abnormal anatomical run-off are NOT excluded. Important is to see that the there is a run-off to the foot and/or wound area even if collaterals are involved.
9. Haemodynamically significant inflow stenoses of vessels above the knee were successfully treated before.
10. Lesions must be crossed successfully with a guide wire and guide wire must be within the true lumen of the distal vessel.

Notes:

* Target vessel has to be defined; Target vessel = vessel with target lesion to be treated
* Target vessel: Multiple or diffused lesions with total length \> 190 mm =\> inclusion criteria are NOT fulfilled
* NON-target vessel(s): haemodynamically significant lesion can be treated according to investigator's discretion

Exclusion Criteria:

1. Patient refuses treatment.
2. Patient is legally, physically or mentally unable to give consent.
3. ABI / TBI measurement is impossible.
4. Target lesion is pre-treated.
5. Target lesion lies within or adjacent to an aneurysm.
6. Acute thrombus present in the target limb.
7. The reference vessel diameter is not suitable for available stent size (RVD \< 2.5 and \> 4.0 mm).
8. Length of lesion requires more than one treatment device (lesion length \> 190 mm)
9. Hybrid technique (bypass surgery and peripheral intervention with PTA or stent during the same session) is not allowed. Note: Allowed is if the patient got a P1 or P3 bypass in a previous session and it is possible to treat a distal lesion through that bypass in a separate session. Time window between bypass surgery and planned intervention must be at least 30 days.
10. Life-expectancy less than 12 months at the time of screening.
11. Patient has a known allergy to heparin, aspirin, clopidogrel or other anticoagulant/ antiplatelet therapies, to nickel or contrast media or is unwilling to tolerate such therapies.
12. Patient has bleeding diatheses
13. Patient is currently enrolled in another investigational device or drug trial.
14. Patient took part in another investigational device or drug trial within 3 months prior to screening.
15. Patient is currently breast-feeding, pregnant or intends to become pregnant.
16. Myocardial infarction without coronary revascularization \< 6 months prior to screening and with coronary revascularization \< 1 month prior to screening.
17. Previous coronary or peripheral bypass surgery within 30 days prior to screening.
18. Patient had a calculated creatinine clearance \< 30 ml/min within 30 days prior to screening.
19. Patient had a stroke or TIA within the last 6 months prior to screening.
20. Patient had a major amputation of the target limb (defined as above the ankle) at the time of screening
D: Inclusion Criteria:

* Written informed consent
* Age \> 18 years
* If female patient with child bearing potential, patient may not be pregnant at the study entry and must utilize reliable birth control for the duration of her participation into the study
* Patient is willing and able to comply with the specified follow-up evaluation
* Critical Limb Ischaemia, this is Fontaine stage III (ischaemic rest pain) and IV (ischaemic ulcers or gangrene) or Rutherford category 4 (ischaemic rest pain), 5 (minor tissue loss) or 6 (major tissue loss)
* Stenotic (\>50% luminal loss) or occluded infrapopliteal artery, including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery and the peroneal artery, with a lesion length ≤ 60 mm
* Artery to be treated with a diameter more tham or equal to 2mm and less than or equal to 4mm
* Patent common iliac, external iliac, superficial femoral and popliteal artery on the ipsilateral side prior to randomisation, possibly after treatment during the same session
* At least one patent crural (anterior tibial, posterior tibial or peroneal) artery with expected unobstructed runoff to ankle level after treatment

Exclusion Criteria:

* Acute limb ischaemia
* Subacute limb ischaemia which requires thrombolysis as first treatment modality
* Active bleeding or bleeding diathesis
* Recent (less than 3 months) hemorrhagic stroke or other any other CNS abnormality with increased risk of haemorrhage, such as intracranial neoplasm, arteriovenous malformation, intracranial aneurysm or aneurysm repair
* Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks before treatment
* Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side
* Revascularization involving the same limb within 30 days prior to the index procedure or planned revascularization of the same limb within 30 days of the index procedure
* Previous implanted stent at the index site
* Life expectancy of less than 6 months or other factors making clinical follow-up difficult
* Known allergy to acetylsalicylic acid (aspirin), clopidogrel, heparin or paclitaxel
* Known allergy to contrast media
* Known heparin induced thrombocytopenia (HIT type 2)
* Patient unable or unwilling to tolerate anticoagulant, anti-platelet therapy or contrast media
* Creatinine clearance \< 20 ml/min (as derived from Cockcroft-Gault or MDRD formula)unless patient is on hemodialysis
* Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side
* Severely calcified lesions with expected resistance to stenting
* Poor inflow due to ipsilateral stenoses or occlusions of the iliac or femoropopliteal arteries that cannot be treated during the same session
* Significant vessel tortuosity or other parameters prohibiting access to the lesions and/or delivery of the stent
* Patients without (expected) distal runoff to the index site
* Previous implanted stent at the index site

Answer: A