Effect of Lipid Modification on Peripheral Arterial Disease After Endovascular Intervention (The ELIMIT Trial)

Status: Completed
Location: See location...
Intervention Type: Drug, Procedure, Behavioral
Study Type: Interventional
Study Phase: Phase 4

Peripheral arterial disease (PAD) occurs when arteries become narrowed or hardened because of a build-up of plaque or fat deposits. PAD develops most often in arteries in the legs, which can result in reduced blood flow to the legs and feet, occasionally causing leg pain and fatigue. Early identification of PAD and treatment with lifestyle changes or medications can help to keep legs healthy and lower risk for heart attack and stroke, but endovascular or surgical procedures may be necessary for people with severe PAD. Even after endovascular intervention, PAD symptoms must be continually monitored to prevent the development and progression of blockages in the arteries. The best approach for monitoring symptoms is still undetermined. This study will compare the effectiveness of an intensive combination of lipid modifying medications versus standard lipid modifying medications in treating people with significant PAD who have had an endovascular intervention.

Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: No

• Symptoms consistent with calf claudication and described as life style limiting

• Objective evidence of peripheral artery disease (PAD): Ankle brachial index less than 0.9 OR other hemodynamic or imaging modalities confirming significant PAD

• Baseline imaging reveals superficial femoral artery (SFA) disease starting at least 5 cm from the origin of the SFA

• Agrees to be available for follow-up and is able to participate in all study testing procedures

• Weight and/or body characteristics that will allow testing with MRI

• No known contraindication to lipid lowering agents

• Serum creatinine level less than 2.5 mg/dL

• Scheduled to undergo or has already undergone an endovascular intervention of a de novo lesion in the SFA with an anticipated result that would satisfy hemodynamic stability OR is medically managed and does not require an intervention at this time

• Compressible arteries (if not, has toe brachial index [TBI] less than 0.7)

• Has/had an A, B, C lesion amendable to a catheter based therapy (prior bypass is acceptable)

United States
Baylor College of Medicine
Time Frame
Start Date: April 2004
Completion Date: December 2010
Target number of participants: 102
Experimental: 1
Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.
Active Comparator: 2
Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov

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