Table 1.

CLEVER Study Eligibility Criteria. Scoring of the San Diego Claudication Questionnaire for CLEVER eligibility is unique to this study and explained in the protocol. All duplex ultrasound, MRA and CTA images are submitted to the duplex core lab or Clinical Coordinating Center for over read.

Inclusion Criteria
1.	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.
2.	Subject is ≥ 40 years old.
3.	Subject has resting ipsilateral ankle-brachial index (ABI) <0.9.
4.	Claudication score consistent with “Rose”, “atypical”, or “noncalf” claudication by San Diego Claudication Questionnaire (see Appendix A for acceptable responses)
5.	Significant lower extremity artery PAD on the most symptomatic side(s) (bilaterally if symptoms are equal):
	5.1	For Aortoiliac Insufficiency
	a.	Contrast Arteriography: Contrast arteriogram showing at least 50% stenosis in the aorta, common iliac artery, or external iliac artery, OR
	b.	CTA or MRA: 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
	c.	Duplex Ultrasound: Occlusion of 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
	d.	Vascular Noninvasive Physiologic Tests: Resting thigh-brachial index (thigh-BI) < 1.1, and common femoral artery Doppler systolic acceleration time >140 msec [these tests may be ordered for study screening].
	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.
	5.2	For Femoropopliteal Artery Insufficiency
		Contrast Arteriography or CTA or MRA: At least 50% stenosis in the femoropopliteal segment between 5 mm past the origin of the superficial femoral artery to the popliteal artery at least 3 cm cephalad to the knee joint. Cumulative lesion length (adding up the total lengths of disease segments) must be less than 25 cm long. There must be no significant arterial obstruction caudal to 3 cm above the knee joint, and there must be at least one calf artery patent to at least the ankle level (peroneal artery to its bifurcation qualifies).
6.	Highest ankle pressure reduced by at least 25 mm Hg after exercise compared to resting pressure.
		Note: The highest ankle pressure result is determined by using the higher result of either the dorsalis pedis or posterior tibial artery measurement.
7.	Subject has moderate to severe claudication symptoms, defined as less than 9 minutes MWD at baseline (initial) Gardner treadmill test (see Appendix B).
8.	Performance on a second Gardner treadmill test within 25% of the initial baseline MWD test result.
3.3.2.	Exclusion Criteria
1.	Presence of critical limb ischemia (Rutherford Grade II or III PAD, defined as pain at rest, ischemic ulceration, gangrene) or acute limb ischemia (pain, pallor, pulselessness, paresthesias, paralysis) in either leg.
2.	Common femoral artery (CFA) occlusion or >=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
3.	Known total aortic occlusion from the renal arteries to the bifurcation of the aorta.
4.	Patient has bilateral aortoiliac arterial insufficiency but one side is anatomically ineligible (e.g., not amenable to stenting due to common femoral artery stenosis or occlusion).
5.	If aortoiliac and femoropopliteal arterial insufficiency coexist on the same side, and aortoiliac insufficiency is not revascularizable due to total aortoiliac occlusion from the renal arteries through the external iliac arteries, or due to common femoral artery significant (>=50%) stenosis or occlusion, patients are ineligible. [Patients with combined aortoiliac and femoropopliteal insufficiency can be enrolled if aortoiliac insufficiency meets eligibility criteria even if femoropopliteal insufficiency doesn’t meet anatomic eligibility criteria. Therefore, if a patient has significant (at least 50% by diameter) stenosis in the aorta or iliac arteries, and has ipsilateral femoropopliteal artery disease which is anatomically ineligible, they can be enrolled under the “Aortoiliac Insufficiency” Criteria above (section 3.3.1, number 5).] Patients with extensive femoropopliteal disease exceeding inclusion criteria and qualifying aortoiliac disease can be enrolled but intervention should not be done in the femoropopliteal segment.
6.	Participant has bilateral claudication symptoms and the limb that is more symptomatic does not show evidence of aortoiliac insufficiency or femoropopliteal artery insufficiency as described in inclusion criterion number 5.
7.	Participant has bilateral claudication symptoms, but both limbs are equally symptomatic but one side does not show evidence of aortoiliac insufficiency or femoropopliteal artery insufficiency as described in inclusion criterion number 5.
8.	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>180 mm Hg)
	iii	Poorly-controlled diabetes mellitus
	iv	Other active significant medical problems such as cancer, known chronic renal disease (serum creatinine >2.0 mg/dl within 90 days or renal replacement therapy), known chronic liver disease or anemia, active substance abuse, or known history of dementia.
9.	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
10.	Subject is eligible due to only aortoiliac insufficiency and has had previous ipsilateral aortic or iliac artery revascularization (surgery or intervention).
11.	Subject is eligible due to only femoropopliteal artery insufficiency and has had previous ipsilateral femoropopliteal artery revascularization (surgery or intervention) [if qualified by both aortoiliac and femoropopliteal artery insufficiency and prior femoropopliteal artery intervention has been done the participant can be eligible and femoropopliteal intervention or surgery can be done at the operator’s discretion if restenosis is present].
12.	Recent major surgery in the last 3 months.
13.	Abdominal aortic aneurysm > 4 cm or iliac artery aneurysm >1.5 cm is present.
14.	Patients who are pregnant, planning to become pregnant, or lactating.
15.	Unwilling or unable to attend regular (3 times a week) supervised exercise sessions. {Please review this commitment carefully with each prospective participant}
16.	Weight >350 lbs or 159 kg (may exceed treadmill and angiography table limits).
17.	Language barrier exists for primary QoL instruments (available in English and Spanish).
18.	Inability to understand and sign informed consent forms due to cognitive or language barriers (interpreter permitted).
19.	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.
20.	Allergy to stainless steel or nitinol.
21.	Allergy or other intolerance to cilostazol (bleeding history) or history of congestive heart failure [if ejection fraction is shown to be >=50% patient may be enrolled]
22.	Nonatherosclerotic cause of PAD (fibromuscular dysplasia, dissection, trauma, etc).
23.	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.
24.	ST-segment depression >1 mm in any of the standard 12 ECG leads or sustained (>30 seconds) arrhythmia other than tachycardia or occasional premature atrial or ventricular contractions during exercise testing.
25.	Post-exercise systolic blood pressure within the first five minutes after eligibility treadmill test lower than pre-exercise systolic blood pressure.
26.	A peak heart rate ≥80% of maximum (calculated by subtracting age from 220) while reporting ”onset” of claudication symptoms (level 3 or 4) during the second baseline examination.
27.	Repeat treadmill test shows a MWD result that is >25% different than the subject’s initial Gardner treadmill test result.
28.	Current active involved in a supervised exercise program (e.g., cardiac rehabilitation) for more than 2 weeks within the prior 6 weeks.