February 2, 2009 - Boston Scientific Corp. today said it began patient enrollment in the PLATINUM clinical trial, which is designed to evaluate the company’s PROMUS Element Everolimus-Eluting Coronary Stent.
The first U.S. patient was enrolled last week at the Medical Center of the Rockies in Loveland, Colorado by Thomas Downes, M.D. The first Japanese patient was also enrolled last week.
The PLATINUM clinical program will enroll 1,728 patients at 160 sites worldwide. The trial will compare the PROMUS Element Everolimus-Eluting Coronary Stent to the PROMUS Everolimus-Eluting Coronary Stent. The company plans to develop additional variations of the Element Stent platform, including next generations of a bare-metal stent and a paclitaxel-eluting TAXUS Element Stent.
The Element Stent platform features a proprietary Platinum Chromium Alloy, designed specifically for coronary stents. This alloy, coupled with new stent architecture, is designed to enable thinner struts, increased flexibility and a lower profile while improving radial strength, recoil and visibility. In addition, the PROMUS Element Stent System incorporates the new Apex Dilatation Catheter technology, designed to enhance deliverability to complex lesions.
The global principal investigator for the trial is Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation in New York. The U.S. co-principal investigator is Paul Teirstein, M.D., of Scripps Green Hospital in La Jolla, California, and the international co-principal investigator is Ian Meredith, M.D., Ph.D., director of cardiology at the Monash Medical Centre in Melbourne, Australia.
“The new alloy and stent design of the PROMUS Element Stent promise to offer improved deliverability and visibility, even in patients with complex and challenging anatomy,” said Dr. Stone. "I am enthusiastic about the possibility of having both everolimus and paclitaxel versions of this innovative stent system available, allowing for the tailored treatment of patients with coronary artery disease."
The PLATINUM clinical program will evaluate the safety and efficacy of the PROMUS Element Stent in three studies. The first, PROMUS PLATINUM Workhorse, will evaluate the safety and efficacy of the PROMUS Element Stent compared to Boston Scientific's PROMUS Stent. This 1:1 randomized study will evaluate 1,532 patients from 160 global sites with de novo "workhorse" lesions from 2.5 to 4.25 mm in diameter and less than 24 mm in length. The primary endpoint of the workhorse study is target lesion failure (TLF) at 12 months, with clinical follow-up scheduled out to five years.
Two additional parallel studies will evaluate the PROMUS Element Stent in small vessels and long lesions. The small vessel study will examine lesions from 2.25 to 2.5 mm in diameter and less than or equal to 28 mm in length, while the long lesion study will examine lesions from 2.5 to 4.25 mm in diameter and 24 to 34 mm in length. The primary endpoint of both studies is TLF at 12 months.
For more information: www.bostonscientific.com