Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of the Pantheris Optical Coherence Tomography Imaging Atherectomy System for Use in the Peripheral Vasculature
Brief Summary: A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an atherectomy device that provides directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque in diseased lower extremity arteries.


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:

* Patient has signed and dated the informed consent.
* Patient has up to 2 documented stenotic or occluded atherosclerotic lesions (up ro 14 cm long) of the above-the-knee femoropopliteal artery, up to one in each limb, that meet all of the inclusion criteria and none of the exclusion criteria.
* Patient has a de novo or restenotic lesion(s) with \>50% stenosis documented angiographically and no prior stent in the target lesion.
* Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.
* Patient has a resting Ankle Brachial Index (ABI) \<0.9 or an abnormal exercise ABI if resting ABI is normal. Patient with incompressible arteries (ABI \>1.2) must have a Toe Brachial Index (TBI) \<0.8.
* Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 months, 12 months, and at 2, 3, 4, and 5 years.
* Patient agrees to return for x-rays at 6 and 12 months.
* Patient agrees to return for angiography at 12 months.
* Patient agrees to be contacted by telephone at 1, 3, 9, and 18 months to assess clinical status.

Exclusion Criteria:

* Patient is pregnant or breast-feeding.
* Patient is simultaneously participating in another investigational drug or device study.
* Patient has significant stenosis or occlusion of inflow tract not successfully treated before this procedure.
* Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
* Patient has had previous stenting of target vessel.
* Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
* Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol and, in the opinion of the investigator, cannot be adequately premedicated.
* Patient lacks at least one patent vessel of runoff with \<50% stenosis throughout its course.
* Patient has untreated angiographically-evident thrombus in the target lesion.

\[Additional criteria may apply.\]
C: 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
D: Inclusion Criteria:

* Age ≥ 18 years old;
* Subject is a candidate for percutaneous intervention for peripheral arterial disease in the legs;
* Subject is willing and able to give informed consent;
* Documented symptomatic atherosclerotic peripheral arterial disease Rutherford Classification 2-5;
* Reference vessel lumen proximal to target lesion ≥ 2.5 mm and ≤ 7.0 mm in diameter by visual estimation;
* Subject has de novo target lesion(s) with stenosis \>70% by visual estimation distal to the profunda femoral artery. No more than 2 lesions may be treated with the Pantheris device;
* Target lesion length ≤ 15 cm (may be two tandem lesions that do not exceed 15cm in total length);
* Subject is capable of meeting requirements and be present at the follow-up clinic visits at 30 days and 6 months;
* At least one patent tibial run-off vessel at baseline.

Inclusion Criteria for the 24-month follow up:

* Completed the 6-month follow-up visit
* Re-consented prior to the 24-month follow-up visit

Exclusion Criteria:

* Subject is pregnant or breast feeding;
* Rutherford Class 0 to 1 (asymptomatic and mild claudication);
* Rutherford Class 6 (critical limb ischemia);
* Moderate to severe calcification of the target lesion;
* Acute ischemia and/or acute thrombosis of the Superficial Femoral Artery (SFA)-Popliteal segment;
* In-stent restenosis within the target lesion;
* Target lesion with any type of stent or graft;
* Target lesion in the iliac artery;
* Target lesion stenosis \<70%;
* Subjects with significant (≥70%) occlusive lesions proximal to the target lesion not successfully treated during the index procedure (upstream disease) and prior to treatment of the target lesion;
* Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure;
* Planned endovascular or surgical procedure 30 days after the index procedure;
* Lesion in the contralateral limb requiring intervention during the index procedure or within 30 days of the index procedure;
* Subjects with active systemic infections whether they are being currently treated or not;
* Subjects on chronic hemodialysis or creatinine level \>2.0mg/dL;
* Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months;
* Evidence or history of aneurysmal target vessel within the past 2 months;
* History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days;
* Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated;
* Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated;
* History of heparin-induced thrombocytopenia (HIT);
* Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/mm2, known coagulopathy, or International Normalized Ratio (INR) \>1.5;
* Any thrombolytic therapy within 2 weeks of the index procedure;
* Any clinical and/or angiographic complication attributed to the use of another device prior to the insertion of the study device into the subject;
* Subjects or their legal guardians who have not or will not sign the Informed Consent;
* Subjects who are unwilling or unable to comply with the follow-up study requirements;
* Participation in any study of an investigational device, medication, biologic or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of the study.

Answer: D