Please select the eligibility criteria that correspond to the clinical trial below.
Title: Drug Eluting Balloon in peripherAl inTErvention for In-Stent Restenosis: the DEBATE-ISR Study
Brief Summary: The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed versus conventional balloon angioplasty in superficial femoral artery and popliteal artery re-stenosis.


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: General Inclusion Criteria:

* Patient presenting with lifestyle-limiting claudication, rest pain or minor tissue loss (Rutherford classification from 2 to 5)
* Patient is willing to comply with specified follow-up evaluations at the specified times
* Patient is \>18 years old
* Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
* Patient has a projected life-expectancy of at least 24 months
* Noninvasive lower extremity arterial studies (resting or exercise) demonstrate ankle-brachial index ≤0.8
* Patient is eligible for treatment with the Viabahn® Endoprosthesis (W.L. Gore)
* Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure

Angiographic Inclusion Criteria

* Restenotic or reoccluded lesion located in a stent which was previously implanted (\>30 days) in the superficial femoral artery, suitable for endovascular therapy
* Total target lesion length between 4 and 27 cm (comprising in-stent restenosis and adjacent stenotic disease)
* Minimum of 1.0cm of healthy vessel (non-stenotic) both proximal and distal to the treatment area
* Popliteal artery is patent at the intercondylar fossa of the femur to P3
* Target vessel diameter visually estimated to be \>4mm and \<7.6 mm at the proximal and distal treatment segments within the SFA
* Guidewire and delivery system successfully traversed lesion
* There is angiographic evidence of at least one-vessel-runoff to the foot, that does not require intervention (\<50% stenotic)

Exclusion criteria :

* Untreated flow-limiting aortoiliac stenotic disease
* Presence of a chronic total occlusion, i.e. a complete occlusion of the failed bare stent that cannot be re-opened with thrombolysis or does not allow easy passage of the guidewire by the physician
* Any previous surgery in the target vessel
* Severe ipsilateral common/deep femoral disease requiring surgical reintervention
* Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
* Femoral or popliteal aneurysm located at the target vessel
* Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
* No patent tibial arteries (\>50% stenosis)
* Prior ipsilateral femoral artery bypass
* Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 2-year life expectancy
* Serum creatinine \>2.5mg/dL within 45 days prior to study procedure unless the subject is currently on dialysis
* Major distal amputation (above the transmetatarsal) in the study or non-study limb
* Septicemia or bacteremia
* Any previously known coagulation disorder, including hypercoagulability
* Contraindication to anticoagulation or antiplatelet therapy
* Known allergies to stent or stent graft components (nickel-titanium or ePTFE)
* Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
* Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
* Currently participating in another clinical research trial, unless approved by W.L. Gore \& Associates in advance of study enrolment
* Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment
* Any planned surgical intervention/procedure within 30 days of the study procedure
* Target lesion access not performed by transfemoral approach.
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:

* 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

Answer: D