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.

For more information: www.bostonscientific.com

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init