Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Trial of Paclitaxel Eluting Balloon or Conventional Balloon for Treatment of In-Stent Restenosis of the Superficial Femoral Artery in Patients With Symptomatic Peripheral Artery Disease (ISAR-PEBIS)
Brief Summary: The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral artery in-stent restenosis.


Options:
A: Inclusion Criteria:

* PAD with Rutherford class 1-4
* Resting ABI \<0.9 or abnormal exercise ABI \<0.9
* History of previous femoropopliteal nitinol stenting
* Angiographic significant restenosis (\>=50%)
* Target lesion length \>=4 cm; no more than 3 cm outside stent at either end
* Vessel diameter \>=5 mm and \<=7 mm
* At least one widely patent tibial or peroneal artery to the foot

Exclusion Criteria:

* Patient is pregnant or breast feeding
* Evidence of acute limb ischemia
* Life expectancy \<12 months
* CVA within 60 days of screening
* Myocardial infarction within 60 days of procedure
* Known allergy to contract media
* Known contraindication to aspirin, antiplatelet and anti-coagulation therapies
* Uncontrolled hypercoagulability
* Present or suspected systemic infection in target limb
* Serum creatinine \>= 2.5 mg/dl unless dialysis dependent
* Previous treatment to target vessel within 3 months of study procedure
* Drug eluting stents or covered stents in target lesion
* Ipsilateral and/or contralateral iliac stenosis \>= 50% DS that is not successfully treated prior to index procedure or with final residual stenosis \<= 30% documented by angiography
* Planned or predicted cardiovascular surgical or interventional procedures prior to completion of the 30-day follow-up
* Identification of any lesion below the target stent in the treated leg \>50% that will require preplanned or predicted treatment within 30 days(prior to the 6 month follow up)
* Tibial artery containing a \>50% Diameter Stenosis (DS) by visual estimate after popliteal
* Grade 4 or 5 stent fracture affecting target stent or proximal to the target stent, or where evidence of stent protrusion into the lumen is noted on angiography in 2 orthogonal views.
B: Inclusion Criteria:

* age\>18 years
* intermittent claudication (Fontane III or IV)
* angiographic stenosis\>50% or occlusion of superficial femoral-popliteal artery\>40mm, previously treated with nitinol stent implantation, with 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
* need for amputation
* angiographic evidence of stent fracture
C: Inclusion Criteria:

All criteria 1-6 should apply for inclusion.

1. Age \> 50 years
2. Patient legally authorized to provide written informed consent
3. Patient willing and likely to comply with the follow up schedule
4. Patient symptomatic Rutherford-Becker 2-5 (Fontaine II-IV)
5. In-stent restenosis in the SFA and P1 segment of the popliteal artery (PA)
6. Tibial run-off of at least 1 artery which however may be stenotic but amenable to PTA

Exclusion Criteria:

1. Patients unable to give informed consent
2. Patients enrolled in another study with any investigational drug or device
3. Major surgical procedures (not including minor amputations) within 30 days prior to this study or planned within 30 days of entry into this study
4. Pregnancy
5. Patients with any known allergy, hypersensitivity or intolerance to radiologic contrast media, ASA, Clopidogrel or Ticlopidine, Paclitaxel
6. Life expectancy of \< 1 years
D: Inclusion Criteria:

* Symptomatic ≥ 70% in-stent restenosis of the AFS, (Rutherford stage 2-6)
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study

Exclusion Criteria:

* Acute ischemia and/or acute thrombosis of the SFA
* Untreated ipsilateral iliac artery stenosis \>70%
* Not at least one vessel run-off
* Popliteal involvement with stenosis \>70%
* Severe renal insufficiency (GFR \<30 ml/min/m2)
* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
* Pregnancy (present, suspected or planned) or positive pregnancy test.
* Previous enrollment in this trial.
* Patient's inability to fully cooperate with the study protocol.

Answer: D