STROLL is a multicenter, non-randomized, 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 ≥ 4.0 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 will follow patients out to three years with mandatory X-Ray and DUS at all key follow-up points.The STROLL study represents the latest commitment by Cordis to continue its groundbreaking work in the fight against vascular disease. Late last year, the U.S. Food and Drug Administration (FDA) approved the S.M.A.R.T.® CONTROL® Vascular Stent Systems for use in the superficial femoral artery (SFA) and/or the proximal popliteal artery (PPA). 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. 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. *Defined as Rutherford-Becker classification 0 or 1.
Reference: 1. Data on file, Cordis Corporation.