Please select the eligibility criteria that correspond to the clinical trial below.
Title: Directional AthErectomy Followed by a PaclItaxel-Coated BallooN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment
Brief Summary: The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment with the Cotavance™ drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial disease.


Options:
A: 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.
B: 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
C: Inclusion Criteria:

* Rutherford Clinical Category 2-4
* At least 18 years of age
* Is able and willing to provide written informed consent prior to study specific procedures

Exclusion Criteria:

* Has a life expectancy of less than 24 months
* Is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing
* Has one or more of the contraindications listed in the SilverHawk/ TurboHawk or Cotavance IFUs
D: 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

Answer: C