Please select the eligibility criteria that correspond to the clinical trial below.
Title: Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)
Brief Summary: This is a prospective randomized controlled trial to compare clinical improvement, cost effectiveness and patency rates between new and improved Nitinol stents and open bypass surgery in the superficial femoral artery disease.

Secondary outcomes also include comparing quality of life, re-intervention rate, mortality, morbidity and time to return to work or regular activities.

Patients with superficial femoral artery lesions will be considered. Patients with TASC II A lesions will not be randomized but treated with PTA/stenting as standard of care. Patients with TASC II B and C lesions will be prospectively randomized into either receiving open bypass or stenting.

Patients with TASC D lesions will be treated with open bypass surgery after angiography.

The investigators will collect pre-procedure, peri-procedural and clinical follow-up data on all enrolled the patients.


Options:
A: Inclusion Criteria:

* Subject has symptoms suggestive of intermittent claudication, such as exercise-induced pain, cramps, fatigue, or other equivalent discomfort, involving large muscle groups of the leg(s) (calf, thigh, buttocks), relieved by rest
* Claudication score consistent with "Rose", "atypical", or "noncalf" claudication by San Diego Claudication Questionnaire
* Positive noninvasive evaluation for significant aortoiliac PAD on the most symptomatic side(s) (bilaterally if symptoms are equal):

  * Contrast Arteriography: Contrast arteriogram showing at least 50% stenosis in the aorta, common iliac artery, or external iliac artery, OR
  * CTA or MRA: Ankle-brachial index less than or equal to 0.9 (or abnormal ankle PVR waveform at ankle if arteries are incompressible\*) with at least 60% stenosis in the aorta, common iliac artery, external iliac artery, accompanied by a biphasic or monophasic Doppler wave form at the common femoral artery (loss of early diastolic flow reversal or loss of forward flow during diastole), OR
  * Duplex Ultrasound: Ankle-brachial index less than or equal to 0.9 (or abnormal ankle PVR waveform at ankle if arteries are incompressible\*) with occlusion or focal doubling of peak systolic velocity in the aorta, common iliac artery, or external iliac artery, accompanied by a biphasic or monophasic Doppler wave form at the common femoral artery (loss of early diastolic flow reversal or loss of forward flow during diastole), OR
  * Vascular Noninvasive Physiologic Tests: Ankle-brachial index less than or equal to 0.9 (or abnormal ankle PVR waveform at ankle if arteries are incompressible\*) with resting thigh-brachial index (thigh-BI) less than 1.1, and common femoral artery Doppler systolic acceleration time greater than 140 msec \[these tests may be ordered for study screening\].

    * Abnormal PVR waveform must lack augmentation at the ankle, have a delayed, rounded systolic peak, and straight or convex downslope, and must be reviewed by the core lab.

Note: MRA/CTA, and contrast arteriogram images images must be submitted to the Clinical Coordinating Center and Doppler waveform tracings to the Noninvasive Test Committee for over read pre- or post-randomization

* Highest ankle pressure reduced by at least 25 mm Hg after exercise compared to resting pressure (or loss of previously present Doppler signal for both the posterior tibial and anterior tibial arteries immediately after exercise if arteries were incompressible) Note: The highest ankle pressure result is determined by using the higher result of either the dorsalis pedis or posterior tibial artery measurement.
* Subject has moderate to severe claudication symptoms, defined as less than 11 minutes MWD at baseline (initial) Gardner treadmill test

Exclusion Criteria:

* Presence of critical limb ischemia (Rutherford Grade II or III59 PAD, defined as pain at rest, ischemic ulceration, gangrene) or acute limb ischemia (pain, pallor, pulselessness, paresthesias, paralysis) in either leg
* Common femoral artery (CFA) occlusion or greater than or equal to 50% stenosis by angiography, MRA, CTA, or duplex ultrasound or doubling of systolic velocity in the ipsilateral common femoral artery by duplex ultrasound, or 50% diameter stenosis by visual estimate in the CFA by angiography, MRA, or CTA, (inadequate outflow for iliac stent intervention), if available pre-randomization
* Known total aortoiliac occlusion from the renal arteries to the inguinal ligaments (all other occlusions, including aortic occlusion, ARE eligible)
* Participant has bilateral claudication symptoms and the limb that is more symptomatic does not show evidence of aortoiliac insufficiency as described in inclusion criterion number 5
* Participant has bilateral claudication symptoms, but both limbs are equally symptomatic and one side does not show evidence of aortoiliac insufficiency as described in inclusion criterion number 5
* Subject meets the following exclusions based upon modified American College of Sports Medicine criteria for exercise training:

  i. Ambulation limited by co-morbid condition other than claudication, for example:1. severe coronary artery disease; 2. angina pectoris; 3. chronic lung disease;4. neurological disorder such as hemiparesis;5. arthritis, or other musculoskeletal conditions including amputation ii. Poorly-controlled hypertension (SBP greater than 180 mm Hg) iii.Poorly-controlled diabetes mellitus iv. Other active significant medical problems such as cancer, known chronic renal disease (serum creatinine greater than 2.0 mg/dl within 60 days or renal replacement therapy), known chronic liver disease or anemia, active substance abuse, or known history of dementia
* Contraindication to exercise testing according to AHA/ACC guideline, specifically: Acute myocardial infarction (within 3-5 days), unstable angina, uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise, active endocarditis, symptomatic severe aortic stenosis, acute pulmonary embolus or pulmonary infarction, acute noncardiac disorder that may affect exercise performance or be aggravated by exercise such as infection, thyrotoxicosis, acute myocarditis or pericarditis, known physical disability that would preclude safe and adequate test performance, known thrombosis of the lower extremity, known left main coronary stenosis or its equivalent, moderate stenotic valvular heart disease, electrolyte abnormalities, known pulmonary hypertension, tachyarrhythmias or bradyarrhythmias, hypertrophic cardiomyopathy, mental impairment leading to inability to cooperate, or high degree atrioventricular block
* Arterial insufficiency of target lesion due to restenosis of an angioplasty/stent or bypass is not eligible
* Recent (less than 3 months) infrainguinal revascularization (surgery or endovascular intervention)
* Recent major surgery in the last 3 months
* Abdominal aortic aneurysm greater than 4 cm or iliac artery aneurysm greater than 1.5 cm is present
* Patients who are pregnant, planning to become pregnant, or lactating
* Unwilling or unable to attend regular (3 times a week) supervised exercise sessions. (Please review this commitment carefully with each prospective participant.)
* Weight greater than 350 lbs or 159 kg (may exceed treadmill and angiography table limits)
* Inability to understand and sign informed consent forms due to cognitive or language barriers (interpreter permitted)
* Absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent) and which would preclude patient from participation in angiographic procedures
* Allergy to stainless steel or nitinol
* Allergy or other intolerance to cilostazol (bleeding history) or history of congestive heart failure \[if ejection fraction is shown to be greater than or equal to 50% patient may be enrolled\]
* Nonatherosclerotic cause of PAD (fibromuscular dysplasia, dissection, trauma, etc)
* Inability to walk on a treadmill without grade at a speed of at least 2 mph for at least 2 minutes on the first treadmill test
* ST-segment depression greater than 1 mm in any of the standard 12 ECG leads or sustained (greater than 30 seconds) arrhythmia other than tachycardia or occasional premature atrial or ventricular contractions during exercise testing
* Post-exercise systolic blood pressure within the first five minutes after eligibility treadmill test lower than pre-exercise systolic blood pressure
* A peak heart rate greater than 80% of maximum (calculated by subtracting age from 220) while reporting "onset" of claudication symptoms (level 3 or 4) during the second baseline examination
* Repeat treadmill test shows a MWD result that is greater than 25% different than the subject's initial Gardner treadmill test result. Current active involvement in a supervised exercise program (e.g., with a trainer, exercise protocol, and goals, such as in cardiac or pulmonary rehabilitation) for more than 2 weeks within the prior 6 weeks.
B: Inclusion Criteria:

* Age over 18 years
* Informed consent
* Novo stenosis, restenosis \>50% or occlusion of the native SFA, all \> 10cm in length
* Patent popliteal artery at the upper margin of the patella to the trifurcation
* Diameter native SFA and popliteal artery are 5.0-7.5 mm
* Indication for surgical bypass
* Distal run-off at least one crural artery without significant stenosis
* Ankle-brachial index (ABI) at rest \< 0.8 in the study limb prior to procedure

Exclusion Criteria:

* Patient unsuitable for administration of contrast agent
* Pregnancy
* Dementia or altered mental status that would prohibit giving conscious informed consent
* Need for adjunctive major surgical or vascular procedures within one month
* Untreated flow-limiting aortoiliac occlusive disease
* Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
* Femoral or popliteal aneurysm of target vessel
* Non-arthrotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
* Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancies, dementia etc.) or other medical condition that would preclude compliance with study protocol
* Major distal amputation (above the transmetatarsal) in the study limb
* Any previously known coagulation disorder, including hypercoagulability
* Contraindication to anticoagulation or antiplatelet therapy
* Known allergies to stent/stent-graft components
* History of prior life-threatening reaction to contrast agent
* Patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
* Planned surgical procedure or major amputation to occur after enrollment of the patient
C: Inclusion Criteria:

* Patients presenting with Fontaine IIB, III, IV ischemia
* Long (\>10 cm) occlusion of the superficial femoral artery, with patent popliteal artery and at least 1 patent crural vessel
* Atherosclerotic disease

Exclusion Criteria:

* Previous operations on the superficial femoral artery
* Radiation therapy groin/leg region
* Diameter superficial femoral artery \< 4 mm
* Contrast allergy
D: Inclusion Criteria:

Clinical Inclusion:

1. Must be at least 18 years of age.
2. Patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB)/Medical Ethics Committee (MEC) of the respective clinical site.
3. Symptomatic patient as evidence by IC or CLI.
4. Patient has failed maximized medical treatment and exercise program.
5. Patient has a resting ABI \< 0.9 or an abnormal exercise ABI if resting ABI is normal.Patient with non-compressible arteries (ABI \> 1.2) must have a TBI \< 0.8.
6. Patient has a de novo or restenotic lesion(s) with \> 50% stenosis documented angiographically.
7. Patient agrees to return for all required clinical contacts following study enrollment.
8. Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure.

Anatomical Inclusion:

1. Patient with any SFA lesion
2. At least one tibial vessel runoff with \< 50% stenosis
3. Lesion starts start at least 1 cm distal to the deep femoral artery
4. Lesion end at least 3 cm above the knee joint
5. Target vessel reference diameter is \> 3 mm \& \< 6.5 mm

Exclusion Criteria:

Clinical exclusion:

1. Known allergic reaction to anesthesia not able to overcome by medication.
2. Known allergic reaction to contrast not able to overcome by medication.
3. Known history of intolerance to study medicating including ASA, clopidogrel, or ticlopidine.
4. Bleeding disorder or refuses blood transfusion.
5. Prior stenting or bypass of SFA (prior PTA is not an exclusion criteria)
6. Unstable angina, recent MI within a month
7. Malignancy or other condition limiting life expectancy to \< 5 years.
8. Renal insufficiency (serum Cr \> 2.0)
9. Patient has any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe (e.g., morbid obesity).

Anatomic Exclusion:

1. Lesion \< 1 cm from origin of DFA
2. Lesion \< 3 cm from the knee joint
3. Chronic total occlusion of SFA \> 20cm.
4. Chronic total occlusion of CFA.
5. Proximal trifurcation occlusions.

Answer: D