News | January 13, 2011

Enrollment Completed for Iliac Artery Stent Trial

January 13, 2011 – Enrollment has finished for the ORION trial designed to test the Epic self-expanding nitinol stent to treat iliac artery disease.

The trial will examine rates of device- and/or procedure-related major adverse events and patency rates at nine months in 125 patients at 28 sites in the United States.

"We are pleased to complete the enrollment phase of this important trial," said Daniel Clair, M.D., FACS, chairman of the department of vascular surgery, The Cleveland Clinic Foundation, and principal investigator of the trial. "Peripheral stenting has become a recognized standard in the treatment of iliac artery disease, and the ORION trial will provide important data on the performance of the Epic stent in treating these types of lesions."

The next-generation Boston Scientific stent is made of self-expanding nitinol and is designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. It employs radial tandem architecture, which is engineered to provide stent flexibility while maintaining predictable radial force characteristics across the entire stent size matrix. The ORION trial incorporates stent diameter ranges from 6 to 12 mm and lengths up to 120 mm. All stent sizes are compatible with 6 French (2.1 mm) sheaths, and the stent delivery system is compatible with 0.035-inch (0.89 mm) guidewires.

"The Epic stent is designed to offer a more balanced stent platform, allowing for excellent radial force without compromising stent flexibility and providing physicians a less-invasive alternative to surgery for treating iliac artery disease," said Joe Fitzgerald, senior vice president and president of Boston Scientific's endovascular unit.

Iliac stenosis (narrowing) occurs when plaque accumulates within the arteries that supply blood to the legs, which can lead to poor blood flow, claudication and other complications. The disease can be treated with medication, surgery or angioplasty.

The Epic nitinol stent system is an investigational device and is limited by applicable law to investigational use only and is not available for sale in the United States.

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