Please select the eligibility criteria that correspond to the clinical trial below.
Title: Infrapopliteal Drug Eluting Angioplasty Versus Stenting for the Treatment of Long-segment Arterial Disease: The IDEAS-I Randomized Controlled Trial.
Brief Summary: In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm will undergo a percutaneous transluminal angioplasty (PTA) with the use of a paclitaxel-coated balloon, while the patients randomized in the drug-eluting stent (DES) study arm will undergo primary stenting using drug-eluting stent(s). The study's primary endpoints will be the 6-month angiographic binary restenosis rate. Secondary endpoints will include the immediate technical success,6-month primary patency, target lesion revascularization and limb salvage and complication rates.


Options:
A: Inclusion Criteria:

* Angiographically documented infrapopliteal disease.
* Rutherford category of peripheral arterial disease between class 3 to 6
* Lesion length between 70 to 220 mm
* Lesions situated in the proximal, mid and mid to distal segments of the tibial vessels.

Exclusion Criteria:

* Lesion length \< 70 mm or \> 220 mm.
* Lesions situated in the distal third of the tibial vessels
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:

* Stenotic (\> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries
* A maximum of two focal target lesions in one or more infrapopliteal vessels
* Length of lesion is maximally 40 mm, allowing maximally 2 stents to be implanted
* Reference vessel diameter should be 2-3.5 mm
* Symptomatic critical limb ischemia (Rutherford 4, 5)
* The patient must be \> 18 years of age
* Life-expectancy of more than 12 months
* The patient has no child bearing potential or negative serum pregnancy test within 7 days of the index procedure
* The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
* The patient must provide written patient informed consent that is approved by the ethics committee

Exclusion Criteria:

* Patient refusing treatment
* The reference segment diameter is not suitable for available stent design.
* Unsuccessfully treated (\>30% residual stenosis) proximal inflow limiting arterial stenosis
* Untreatable lesion located at the distal outflow arteries
* More than two infrapopliteal lesions in the same limb
* Previously implanted stent(s) or PTA at the same lesion site
* Lesion location requiring kissing stent procedure
* Lesion lies within or adjacent to an aneurysm
* Inflow-limiting arterial lesions left untreated
* The patient has a known allergy to heparin, Aspirin or other anticoagulant/anti-platelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
* The patient takes Phenprocoumon (Marcumar).
* The patient has a history of prior life-threatening contrast media reaction.
* The patient is currently enrolled in another investigational device or drug trial.
* The patient is currently breast-feeding, pregnant or intends to become pregnant.
* The patient is mentally ill or retarded.
* Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
* Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days prior to or after the procedure
* Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.) The patient should also not receive inhibitors of CYP3A (such as Itraconazole, and Erythromycin), or inducers of CYP3A (such as Rifampin) within 90 days following the procedure.
* Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
* Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure
D: 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.

Answer: A