First patient enrolled in study evaluating S.M.A.R.T. Nitinol self-expandable stent

Sep 2 2008

Cordis Corporation has announced the first patient enrollment in the STROLL trial, which will evaluate the safety and efficacy of the S.M.A.R.T. Nitinol Self-Expandable Stent System in treating patients with obstructive superficial femoral artery (SFA) disease, also known as SFA atherosclerosis.

The STROLL trial will support a planned PMA filing with the U.S. Food and Drug Administration that, if approved, will allow Cordis to market the S.M.A.R.T. Stent for this important indication.

"PAD remains significantly under diagnosed and leads to increased mortality and morbidity as well as lifestyle and fitness impairment," says Charles Botti, M.D., MidWest Cardiology Research in Columbus, Ohio. "I look forward to better understanding the impact that S.M.A.R.T. Stent may have in the treatment of SFA disease." Dr. Botti performed the procedure on the trial's first patient. Andrew Feiring, M.D., FACC, FSCAI, Columbia St. Mary's in Milwaukee, WI is the STROLL Trial principal investigator. Dr. Feiring receives consulting fees from Cordis Corporation, and he and Dr. Botti receive compensation as STROLL trial investigators.

Atherosclerosis is caused by a buildup of fatty deposits, or plaque, and leads to hardening and narrowing of the arteries, most often in the legs. The SFA is the longest artery in the human body and revascularization (restoration of blood flow) is one of the most commonly performed endovascular procedures today.

"SFA atherosclerosis is the most common disease of the lower extremities and an important area of unmet medical need," says Campbell Rogers, M.D., Chief Technology Officer, Cordis Corporation. "The STROLL trial underscores our commitment to the research and development of treatment options for peripheral vascular disease."

The STROLL trial will enroll approximately 250 patients at 25 centers in the U.S. The primary efficacy endpoint is no significant reduction of flow detectable at 12 months follow-up visit, and no further clinically driven target vessel revascularization performed in the interim. The primary safety endpoint is 30-day freedom from all causes of death, index limb amputation and target lesion revascularization through 30 days.