Providence Medical Research Center is one of approximately 15 research centers nationwide asked to participate in a new research project called CLEVER. This study, sponsored by National Institutes of Health, is for individuals who have blockages in their iliac artery(ies) from a medical condition called peripheral arterial disease. 

The iliac arteries are in the lower abdomen leading to the legs.  Blockages here cause symptoms like pain or cramping in leg or hip muscles when walking, called "claudication."  Several treatment options are available, including:

• Vascular surgery (replacing a portion of your leg artery)
• Stent placement (a metal mesh tube placed through a small tube (catheter) temporarily put into your leg artery)
• Exercise therapy
• Medications

All the above procedures and treatments are accepted standard treatments.  Each has been shown to be effective for improvement of claudication symptoms.  The purpose of the CLEVER study is to compare treatment options, side-by-side, to learn which is the most effective and safe treatment for patients with claudication.

How is the study done?

Individuals interested will undergo screening to determine if they meet the criteria.

Participants will receive the FDA approved medication (cilastozol) at no charge. In addition, they are randomly assigned to one of the following four possible treatment options.

1. Optimal medical care only (defined as risk factor reduction, such as encouragement to stop smoking, and use of home-based unsupervised exercise)
2. Placement of a stent in a blocked leg artery(ies)
3. Supervised exercise therapy in a rehabilitation program
4. Placement of a stent in a leg artery(ies) <u>and </u>supervised exercise therapy in a rehabilitation program

Optimal Medical Care

Participants who receive "optimal medical care" will have the care that many of those with claudication typically receive: advice for risk factor reduction, verbal recommendations for exercise (walking at least 3 times a week) and a medication (cilastozol).

Placement of a Stent

Individuals in this group will have a blocked artery treated by angiography procedure and stent placement, along with the standard treatment from "optimal medical care."

Supervised Exercise/Exercise Maintenance in a Rehab Program

Those who randomize to supervised exercise will be asked to attend exercise sessions  for 1 hour 3 times a week for about 6 months. Utilizing a treadmill, exercise therapists will monitor symptoms and design supportive therapy to help develop improvement in walking tolerance. These sessions are provided free of charge and will be conducted at St. Luke's Rehabilitation Institute. At the end of the six months of supervised exercise, participants will receive guidelines for on going home maintainace exercise. A health educator will follow up by phone at regular intervals to check their progress and offer personal encouragement and suggestions.  This facility is staffed with nurses, doctors and exercise specialists. 

Stenting and Supervised Exercise/Exercise Maintenance

Participants who are randomized to receive the stent and supervised exercise will have the stent placed first.  Then, following a recovery period, they will start the supervised exercise/exercise maintenance training program at St. Luke's. 

Research Results

During the CLEVER trial,  information will be collected from all four groups to compare their response to treatment and to determine statistics regarding the following variables: changes in how far participants can walk without pain, changes in ability to perform normal daily activity, patient-perceived quality of life, and cost-effectiveness.

Researchers hope to find ways to improve care for individuals with peripheral vascular disease.