Study Title

Edwards Lifesciences LLC: A Randomized Study Comparing the Edwards Self-Expanding Life Stent vs. Angioplasty-alone in Lesions Involving the SFA and/or Proximal Popliteal Artery

 Study Details

Study Dates: August 2005 – May 2008 (study to be renewed)

Lead Investigator: Karthikeshwar Kasirajan, MD

This trial will investigate whether the recently designed Edwards Self-Expanding LifeStent in combination with percutaneous transluminal angioplasty (PTA) works as well as PTA alone in treating narrowed/blocked arteries in the leg.

Studies have shown that percutaneous transluminal angioplasty (PTA) and/or stent implantation can successfully re-open significantly narrowed or blocked arteries. In angioplasty, a small balloon is inflated in the narrowed or blocked artery and then deflated so that blood can flow through the vessel. Stent implantation is permanent, requiring that angioplasty be performed initially, after which the stent — a metal (mesh) tube placed on a catheter — is delivered to the narrowed and blocked site in the artery. Upon release from the catheter, the stent expands, pushing the fatty plaque deposits against the wall of the artery to provide a wider channel for blood to flow. In some cases, the surgeon may inflate the balloon inside the stent to insure that it opened completely.

PTA and/or stent implantation are alternatives to surgery. The standard of treatment for narrowed or blocked arteries has been PTA or bypass surgery, which involves bypassing the blocked artery with a plastic tube from a vessel in the abdomen/stomach to a functional vessel in the leg.

 Study Mechanics

Data will be collected over four years. Study participants will be randomly assigned to one of two treatment groups. Group I, the control group, will receive PTA to treat their narrowed/blocked arteries. The test group, Group II, will receive both PTA and stenting to treat their arteries. Afterwards, both groups will be assessed at one, six, 12, 24, 36, and 48 month follow-up examinations, which will include checking devices for treatment related problems, ECG, blood pressure measurement, ultrasound, X-ray (Group II), and completion of a questionnaire.

 Abbreviated Participant Criteria

• Must have an occluded target lesion (blood clot) in the thigh
• Pre-enrollment testing will include an electrocardiogram (ECG), blood tests, and blood pressure measurement in both arms and both legs
• A variety of other exclusions will require examination by an Emory vascular surgeon before eligibility can be determined.

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