Trial Assesses the Safety and Efficacy of the S.M.A.R.T.® Nitinol Self-Expandable Stent System in the Superficial Femoral Artery*
BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Cordis Corporation today announced the presentation of the STROLL study results at the Late Breaking Clinical Trials session at VIVA 2012.
Michael R. Jaff, DO, presented the results of the STROLL study (S.M.A.R.T.® Nitinol Self-Expanding Stent in the TReatment of Obstructive SuperficiaL FemoraL Artery Disease) on behalf of the study investigators. The STROLL study assessed the safety and efficacy of the S.M.A.R.T.® Nitinol Self-Expandable Stent System (S.M.A.R.T.® Stent) in treating patients with obstructive superficial femoral artery (SFA) disease.
“The STROLL trial demonstrates one year patency rates of ~81% and a very low fracture rate,” said Dr. William A. Gray, Director of Endovascular Services, Cardiovascular Research Foundation, New York. “These outcomes both meet and exceed our expectations for patients with symptomatic disease of the superficial femoral artery.”
In the study, the average lesion length was 77 mm, 23.6% of patients presented with total occlusions and 47% of patients were diabetic. Freedom from clinically driven target lesion revascularization (TLR) at one year was 87.4%. The 12-month primary patency rate for the S.M.A.R.T.® Stent was 81.7% by Kaplan Meier estimate. The primary duplex patency rate (PSVR>/=2.5) was 81.1%. There were no major adverse events at 30 days after the initial index procedure. There was also a low rate of stent fractures noted at 12 months (1.8%). All stent fractures were Type I, least severe, there were no incidents of more severe stent fractures (Type II-V).
“We are very pleased with the results of the STROLL study,” said Shlomi Nachman, Worldwide President, Cordis Corporation, “As it achieved the protocol’s prospective primary safety and efficacy endpoints for the S.M.A.R.T.® Stent in the treatment of peripheral artery disease.”
STROLL is a multicenter, non-randomized, single-arm, prospective trial comparing efficacy and safety of the S.M.A.R.T.® Stent with a previously published objective performance goal. Patients ≥30 years of age with de novo or restenotic native SFA lesion(s) or total occlusions with length ≥ 4.0 cm to ≤ 15.0 cm, and reference vessel diameters of ≥ 4.0 mm to ≤ 6.0 mm were included in the study. The 12-month primary patency endpoint was defined as no relevant flow reduction by duplex ultrasonography (DUS) determined by independent core lab, and no interim clinically driven TLR. The primary safety endpoint was 30-day freedom from major adverse events, a composite of all-cause death, index limb amputation and clinically driven TLR. Secondary endpoints cover a variety of morphological, clinical and hemodynamic outcomes.
The STROLL study represents the latest commitment by Cordis to continue its groundbreaking work in the fight against vascular disease.
Dr. Gray is compensated for his services as a member of the company’s scientific advisory board and provides other consulting services.
About Cordis Corporation
Cordis Corporation, part of the Johnson & Johnson family of companies, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com.
* The use of the S.M.A.R.T.® Stent for the treatment of lesions of the SFA is pending approval by the Food and Drug Administration (FDA). The S.M.A.R.T.® Stent is approved for treating atherosclerotic disease of the common and/or external iliac arteries.
For Cordis Corporation
Source: Cordis Corporation