Learn more about what is involved by downloading our Study Participant Frequently Asked Questions (FAQ) or by contacting the research coordinator.

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CLEVER - Peripheral Arterial Disease - Iliac

CLEVER - Peripheral Arterial Disease - Iliac

Title: CLEVER

Study Sponsor: National Institutes of Health Heart, Lung and Blood Institute

Principal Investigator: Alan T. Hirsch MD.

Study Synopsis: This trial is designed to determine optimal treatment for persons who experience pain, cramps, or fatigue in their legs.

If eligible, you may receive one of the 3 treatments:

  1. Optimal Medical Care (claudication drug plus home-based exercise)
  2. Stent Placement (A metal scaffold would be placed in the blocked artery)
  3. Supervised Exercise (Exercise therapy with an instructor for 26 weeks)

Patients will be followed for 18 months. We will be evaluating improvement in walking distance and a decrease of symptoms. Approximately 217 patients from about 30 U.S. and Canadian study sites will be enrolled in this study.

Study Status: Open for enrollment

How do I qualify? Patients who may qualify will have symptoms of leg pain or cramping while walking.

Who do I contact for more information? Holly MacDonald RN or contact research at 612.863.3980

Inclusion Criteria

  1. Symptoms of intermittent claudication
  2. Age > 50
  3. Resting ABI <0.9
  4. Positive noninvasive evaluation for significant aortoiliac PAD
    1. Resting thigh-brachial index < 1.0, and
    2. Either doubling of aortic or iliac artery peak systolic velocity by pulsed Doppler, OR occluded iliac artery by Doppler or angiography, OR common femoral artery Doppler systolic  acceleration time > 140 msec, OR aortoiliac stenosis with at least a 20 mm Hg systolic pressure gradient by simultaneous  catheter measurements.
  5. Ankle pressure reduced by 25 mm Hg after exercise
  6. For diabetics: HbA1C < 8% pre-treadmill
  7. Able to comply with follow-up procedures (i.e., 26 weeks of supervised exercise) and quarterly MD/RC visits

Exclusion Criteria

  1. Critical limb ischemia
  2. Biliateral aortoiliac arterial insufficiency with 1 side not amenable to stenting.
  3. Ambulation limited by co-morbid conditions (i.e., CHF, COPD, etc.)
  4. Contraindication to exercise testing
  5. Previous ipsilateral aortic or iliac artery revascularization
  6. Recent (<1 yr.) infrainguinal revascularization
  7. Abdominal aortic aneurysm >3 cm or iliac artery aneurysm>1.5 cm
  8. Weight > 350 lbs. (159 kg.)
  9. Absolute contraindication to contrast dye
  10. Allergy or intolerance to cilostazol, stainless steel or nitinol
  11. Nonatherosclerotic cause of PAD
  12. Common femoral occlusion by angiography or duplex US