Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective, Randomized, Multi-center, Single-blinded Study for the Treatment of Subjects Presenting With De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using Paclitaxel or Bare Percutaneous Transluminal Angioplasty Balloon Catheter
Brief Summary: This is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon versus bare PTA balloon for the treatment of patients with de novo occluded/stenotic or reoccluded/restenotic lesions of the superficial femoral (SFA) and popliteal arteries.


Options:
A: Inclusion Criteria:

* Symptomatic ≥ 70% stenosis of the SFA (Rutherford stage 2-6)
* Written informed consent

Exclusion Criteria:

* Acute ischemia and/or acute thrombosis of the SFA
* Untreated ipsilateral iliac artery stenosis \>70%
* Previous stenting of the SFA
* Popliteal stenosis \>70%
* Severe renal insufficiency
B: 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
C: Inclusion Criteria:

* Symptomatic leg ischemia requiring treatment of the superficial femoral or popliteal arteries
* Rutherford clinical category 2, 3 or 4
* Male or non-pregnant female at least 18 years

Exclusion Criteria:

* Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries
* Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
* Known intolerance of study medications, paclitaxel or contrast agent
* Active participation in another investigational device or drug study
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: C