Please select the eligibility criteria that correspond to the clinical trial below.
Title: Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation: the DEBATE-BTK Study
Brief Summary: Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK) vessels.


Options:
A: Inclusion Criteria:

* stenosis of the above-the-knee femoropopliteal artery
* appropriate size and location of the lesion

Exclusion Criteria:

* pregnant or breast feeding
* failure or inability to give informed consent
* simultaneously participating in another drug or device study
B: Inclusion Criteria:

1. Subject has provided written informed consent.
2. Subject is willing and able to comply with follow-up evaluations.
3. Subject is ≥ 18 years old.
4. Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the infrapopliteal arteries ≥ 30 mm. Lesions should not extend beyond the ankle joint.
5. A maximum of 2 different vessels can be treated: successful wire crossing is required for the first target vessel before randomization occurs.
6. Subject with PAD or critical limb ischemia according to the current guidelines in need for urgent revascularization to relieve symptoms and improve walking capacity.
7. Reference Vessel Diameter (RVD) 2 - 4 mm, based on visual estimation.
8. Inflow free from flow-limiting lesion confirmed by angiography. Patients with flow-limiting inflow lesions (\> 50% stenosis) can be included if lesion(s) have been treated successfully before the index procedure, with a maximum residual stenosis of 30% per visual assessment.
9. At least one non-occluded crural vessel with angiographically documented run-off to the foot.
10. Successful wire crossing of the lesion.

Exclusion Criteria:

1. Flow-limiting (\> 50% DS) inflow lesion proximal to target lesion, left untreated.
2. Failure to obtain \<30% residual stenosis in a pre-existing haemodynamically significant (\>50% DS) inflow lesion (DEB or DES not allowed for the treatment of inflow lesions).
3. Infrapopliteal lesions extending beyond the ankle joint and involving crural vessels.
4. Acute thrombus in the target vessel (eg complication of inflow lesion treatment) documented by angiogram, if not treated successfully prior to enrolment).
5. Planned major amputation above the ankle of target limb, or any other planned major surgery within 30 days post-procedure.
6. Previous bypass surgery of target vessel.
7. Previously implanted stent in target lesion.
8. Haemorrhagic diathesis or coagulopathy or other disorders such as gastrointestinal ulcerations or cerebral disorders that would restrict prescription of dual anti-platelet therapy.
9. Subject with hepatic failure, deep vein thrombosis, thrombophlebitis, systemic lupus erythematous or subject is on immunosuppressant therapy.
10. Subject with acute MI ≤ 3 months.
11. Renal failure with a creatinine of ≥ 2,5 mg/dl, except patients currently on regular dialysis.
12. Phenprocoumon intake, except for patients who are treated for Arterial Fibrillation. For these patients Phenprocoumon treatment can be interrupted and re-started after treatment with Dual Antiplatelet Therapy for 4 weeks post procedure.
13. Known allergy to contrast media used for angiography that cannot be controlled by pre-medication with steroids and/or antihistaminica.
14. Allergy, intolerance or hypersensitivity to Paclitaxel or related compounds and/or to the delivery matrix n-Butyryl tri-n-hexyl citrate(BTHC).
15. Co- morbid conditions limiting life expectancy ≤ 1 year.
16. Patients that are under active treatment for cancer; Patients, who have been successfully treated for cancer in the past, can be included.
17. Subject is participating in another clinical device trial where the primary endpoint has not yet been reached.
18. Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.
C: 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
D: Inclusion Criteria:

* age\>18 years
* angiographic stenosis\>50% or occlusion of one below-knee vessel

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
* need for amputation

Answer: D