Please select the eligibility criteria that correspond to the clinical trial below.
Title: Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease. A Multicenter, Prospective, Randomized Controlled Trial.
Brief Summary: The primary purpose of this study is to evaluate the long term effects of the polymer-based slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior rotablation, in an angiographically well defined group of patients with complex calcified coronary lesions.


Options:
A: Inclusion Criteria:

* Angiographically proven coronary artery disease
* Angina II-IV° following the Canadian Cardiovascular Society Classification criteria and/or reproducible ischemia in the target area by ECG or scintigraphy
* The patient signing an informed written consent

From the following angiographic criteria, lesions must fulfil all first degree criteria and at least one second-degree criterion to be eligible for inclusion.

First degree criteria

* De-novo lesion in a native coronary artery
* Target reference vessel diameter between 2.5 and 4.0 mm by visual estimation
* Luminal diameter reduction of 70-99% by visual estimation
* Moderate to severe calcification of the target lesion (clearly defined)

Second degree criteria

* Ostial location
* Bifurcational lesions
* Long lesions (≥ 15mm)

Exclusion Criteria:

* Myocardial infarction within 4 weeks
* Left ventricular ejection fraction \< 30%
* Limited long term prognosis due to other conditions

Angiographic exclusion criteria:

* Unprotected left main lesions
* Coronary artery bypass graft stenoses
* In-stent restenoses
* Chronic total occlusions
* Target vessel thrombus
* Target vessel dissection
B: 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.
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:

* Written informed consent approved by the IRB.
* ≥ 18 years old.
* Lifestyle-limiting claudication defined as: Rutherford Cat. 1-3.
* Target lesion(s) is de-novo or restenotic and located within the native SFA and/or proximal popliteal artery
* Angiographic evidence of ≥ 50% stenosis or occlusion
* Target RVD is ≥ 4.0 mm and ≤ 7.0 mm
* Target total length of the lesion or series of lesions is ≤ 150 mm.
* Angiographic evidence of at least one vessel runoff to the foot.

Exclusion Criteria:

* Unable to conform to the study protocol procedures and visits.
* Lifestyle-limiting claudication/CLI (Rutherford Cat. 4-6)
* Patients who are pregnant or planning to become pregnant during the clinical investigation
* Contraindication to study related medications, Ni, Ti, Ta, or other media that is not amenable to pretreatment.
* History of bleeding diatheses or coagulopathy.
* Concomitant renal failure with a creatinine of \> 2.0 mg/dL.
* Concomitant hepatic insufficiency, thrombophlebitis, uremia, SLE, or DVT at the time of the study procedure.
* Receiving dialysis or immunosuppressive therapy.
* Suffered a hemorrhagic stroke ≤ 6 mo prior to the study procedure.
* Prior peripheral vascular bypass surgery involving the target limb.
* Target vessel has been previously stented.
* Target lesion(s) received angioplasty intervention ≤ 6 mo. prior
* Any non-iliac percutaneous intervention(s) \< 7 days prior.
* Currently participating in an investigational drug/device study.
* Limited life expectancy of less than two years.
* Extensive PVD that precludes safe insertion of an sheath.
* Target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s).
* Unresolved thrombus within the target vessel.
* Poor inflow which would not support a vascular bypass graft.
* Diagnosed with septicemia at the time of the study procedure.
* Additional percutaneous interventional procedures (cardiac/peripheral) planned ≤ 30 days following procedure.

Answer: A