Two-Year STROLL Data Presented for Cordis S.M.A.R.T. Stent in Superficial Femoral Artery

January 21, 2013—Cordis Corporation (Bridgewater, NJ) announced that William A. Gray, MD, presented the 2-year results from the STROLL (S.M.A.R.T. Vascular Stent Systems in the Treatment of Obstructive Superficial Femoral Artery Disease) study at ISET 2013, the International Symposium on Endovascular Therapy, in Miami Beach, Florida. The STROLL study assessed the safety and efficacy of the Cordis S.M.A.R.T. vascular stent systems in treating patients with obstructive superficial femoral artery (SFA) disease.

“The 2-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 femoropopliteal vessels, but also the associated patient outcomes, such as Rutherford classification,” commented Dr. Gray in Cordis' press release. Dr. Gray is Director of Endovascular Services at the Cardiovascular Research Foundation in New York, New York.

Cordis detailed the study characteristics in its press release. The average lesion length in STROLL 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 2 years was 80.3%. The 24-month primary patency rate for the S.M.A.R.T. stent was 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%) 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 peripheral artery disease (as measured using Rutherford-Becker classification) in more than 80% of patients and normal ankle-brachial index in 4 of 5 patients at 2 years.

As summarized in the announcement, STROLL is a multicenter, nonrandomized, single-arm, prospective trial comparing the safety and efficacy 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 cm to ≤ 15 cm and reference vessel diameters of ≥ 4 mm to ≤ 6 mm were included in the study. The 12-month primary patency endpoint was defined as no relevant flow reduction by duplex ultrasonography 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 will follow patients out to 3 years with mandatory x-ray and duplex ultrasonography at all key follow-up points.

Late last year, the US Food and Drug Administration approved the S.M.A.R.T. Control vascular stent systems for use in the SFA or proximal popliteal artery. The S.M.A.R.T. stent, which has been approved for peripheral indication in international markets since 1999, is now available in the United States with both iliac and SFA indications.