Please select the eligibility criteria that correspond to the clinical trial below.
Title: Balloon Angioplasty Versus Stenting With Nitinol Stents in the Superficial Femoral Artery
Brief Summary: Minimal invasive treatment (called "endovascular") of the arteries of the lower limb remains problematic, because recurrent disease ("restenosis") frequently leads to recurrent symptoms. As yet, balloon angioplasty remains the recommended strategy to revascularize the superficial femoral artery (artery of the thigh). We investigated whether the use of a vascular endoprosthesis ("stent") improves patients´ outcome.

Study hypothesis: Primary stenting with self expanding nitinol stents may improve patency after endovascular treatment of superficial femoral artery obstructions compared to balloon angioplasty with optional stenting.


Options:
A: 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
B: 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
C: 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
D: Inclusion Criteria:

* Symptomatic peripheral artery disease Rutherford stages 3 to 5
* \>50% stenosis of the ipsilateral superficial femoral artery
* Lesion length \>30mm
* At least one patent crural run-off vessel,

Exclusion Criteria:

* Acute criticla limb ischemia
* Previous ipsilateral bypass surgery or ipsilateral SFA stenting
* Untreated inflow disease
* Known intolerance to clopidogrel, aspirin or radiocontrast

Answer: D