The CLEVER (CLaudication: Exercise Vs. Endoluminal Revascularization) Study is sponsored by the National Institutes of Health’s(NIH) National Heart Lung and Blood Institute (NHBLI). The NHLBI is the premier sponsor of investigations that are internationally considered to be “best in class”. This study is the only multicenter randomized clinical trial for Peripheral Arterial Disease (P.A.D.) that is now comparing supervised exercise with arterial stent placement. This is a major national effort to assure that the public and clinicians know what therapies are most effective, safest, and most cost-effective. Your help is needed.

The CLEVER Study is testing the effectiveness and safety of three different treatments for people with Peripheral Arterial Disease (P.A.D.) and it's main symptom, “claudication”. Eligible participants will be randomly placed into one of the following three groups:

1. Optimal Medical Care group: Participants in this group will receive the standard of care that those with intermittent claudication typically receive, including advice and referral if needed for smoking cessation, recommendations to exercise by walking as much as possible and supplies of the claudication medication cilostazol. Cilostazol is an approved medication that is known to be effective for many individuals with PAD and claudication.

2. Stent Placement group: Participants in this group will receive care similar to the optimal medical care group and will also undergo placement of an arterial stent, a commonly used metallic coil, which is inserted via an X-Ray procedure that will open the blocked artery in the affected leg.

3. Supervised Exercise group: Participants in this group will receive care similar to the optimal medical care group plus access to supervised PAD exercise therapy classes for one hour three times a week for 26 weeks. Following the 26 weeks of supervised exercise, participants will receive monthly calls by a health educator to motivate them to continue to walk regularly at home, until the end of the study.