J&J’s Cordis Corporation today announced the presentation of the two-year STROLL study results at the Abstracts and Late Breaking Clinical Trials session at ISET 2013.
The so-called STROLL study (S.M.A.R.T.® Vascular Stent Systems in the TReatment of Obstructive SuperficiaL FemoraL Artery Disease) assessed the safety and efficacy of the S.M.A.R.T.® Vascular Stent Systems (S.M.A.R.T.® Stent) in treating patients with obstructive superficial femoral artery (SFA) disease.
STROLL is a multicentre, non-randomised, single-arm, prospective trial comparing the safety and efficacy of the S.M.A.R.T.® Stent with a previously published objective performance goal.
In the study, freedom from clinically driven target lesion revascularization (TLR) at two years was 80.3%. with 24-month primary patency rate for the S.M.A.R.T.® Stent of 74.9% by Kaplan Meier estimate.
The primary duplex patency rate (PSVR>/=2.5) was 83.5%. 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 (2.0%) with no additional fractures reported out to 24 months. All stent fractures were Type I, least severe, and there were no incidents of more severe stent fractures (Type II-V).
In addition to the excellent clinical outcomes in the STROLL study, the clinical data showed an improvement in patient outcomes. This included minimal or no signs of PAD* in more than 80% of patients (as measured using Rutherford-Becker classification), and normal Ankle Brachial Index (ABI) in 4 of 5 patients at 2 years. 1
“The two-year data from the pivotal STROLL trial highlight not only the durability of the clinical outcomes such as patency and target lesion revascularization using the S.M.A.R.T.® Stent in the femoro-popliteal vessels, but also the associated patient outcomes such as Rutherford classification,” said William A. Gray, MD, Director of Endovascular Services, Cardiovascular Research Foundation, New York, who presented the results.
“The exceptional two-year results in the STROLL Study confirm the long-term efficacy of the S.M.A.R.T.® Vascular Stent Systems in the treatment of Peripheral Arterial Disease (PAD),” said Shlomi Nachman, Worldwide President, Cordis Corporation. “Beyond the clinical results, the excellent patient outcomes observed at one year were sustained through the second year. The unique design of the S.M.A.R.T.® Vascular Stent contributed to these results and we look forward to continuing to build on its legacy.”
The S.M.A.R.T.® Stent, which has been approved for peripheral indication in international markets since 1999, is now the first stent in the United States with both Iliac and SFA indications.