Lawrence Garcia1, Michael R Jaff1, Christopher Metzger1, Gino Sedillo1, Ashish Pershad1, Frank Zidar1, Raghotham Patlola1, Robert G Wilkins1, Andrey Espinoza1, Ayman Iskander1, George S Khammar1, Yazan Khatib1, Robert Beasley1, Satyaprakash Makam1, Richard Kovach1, Suraj Kamat1, Luis R Leon1, William Britton Eaves1, Jeffrey J Popma1, Laura Mauri1, Dennis Donohoe1, Carol C Base1, Kenneth Rosenfield2. 1. From the Division of Cardiology, St. Elizabeth Medical Center, Tufts University School of Medicine, Boston, MA (L.G.); Division of Cardiology, Massachusetts General Hospital, Boston (M.R.J., K.R.); Division of Cardiology, Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.); CardioVascular Solutions Institute, Bradenton, FL (G.S.); Division of Cardiology, Banner Good Samaritan Medical Center, Phoenix, AZ (A.P.); Austin Heart, P.A., TX (F.Z.); Cardiovascular Institute of the South, Lafayette, LA (R.P.); Division of Cardiology, Hattiesburg Clinic, P.A., MS (R.G.W.); Hunterdon Cardiovascular Associates, P.A., Flemington, NJ (A.E.); St. Joseph's Hospital Cardiology Associates, Liverpool, NY (A.I.); Division of Cardiology, Plaza Medical Center of Fort Worth, TX (G.S.K.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); Division of Cardiology, Mount Sinai Medical Center, Miami Beach, FL (R.B.); Cardiovascular Research of Northwest Indiana, LLC, Munster, IN (S.M.); Division of Cardiology, Deborah Heart and Lung Center, Browns Mills, NJ (R.K.); Division of Cardiology, Alice Heart Center, TX (S.K.); Division of Cardiology, Tucson Medical Center, AZ (L.R.L.); Division of Cardiology, Willis Knighton Bossier Medical Center, Bossier City, LA (W.B.E.); Division of Cardiology, Beth Israel and Deaconess Medical Center, Boston, MA (J.J.P.); Division of Cardiology, Brigham and Women's Hospital and Harvard Clinical Research Institute, Boston, MA (L.M.); and IDEV Technologies, Inc, Webster, TX (D.D., C.C.B.). 2. From the Division of Cardiology, St. Elizabeth Medical Center, Tufts University School of Medicine, Boston, MA (L.G.); Division of Cardiology, Massachusetts General Hospital, Boston (M.R.J., K.R.); Division of Cardiology, Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.); CardioVascular Solutions Institute, Bradenton, FL (G.S.); Division of Cardiology, Banner Good Samaritan Medical Center, Phoenix, AZ (A.P.); Austin Heart, P.A., TX (F.Z.); Cardiovascular Institute of the South, Lafayette, LA (R.P.); Division of Cardiology, Hattiesburg Clinic, P.A., MS (R.G.W.); Hunterdon Cardiovascular Associates, P.A., Flemington, NJ (A.E.); St. Joseph's Hospital Cardiology Associates, Liverpool, NY (A.I.); Division of Cardiology, Plaza Medical Center of Fort Worth, TX (G.S.K.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); Division of Cardiology, Mount Sinai Medical Center, Miami Beach, FL (R.B.); Cardiovascular Research of Northwest Indiana, LLC, Munster, IN (S.M.); Division of Cardiology, Deborah Heart and Lung Center, Browns Mills, NJ (R.K.); Division of Cardiology, Alice Heart Center, TX (S.K.); Division of Cardiology, Tucson Medical Center, AZ (L.R.L.); Division of Cardiology, Willis Knighton Bossier Medical Center, Bossier City, LA (W.B.E.); Division of Cardiology, Beth Israel and Deaconess Medical Center, Boston, MA (J.J.P.); Division of Cardiology, Brigham and Women's Hospital and Harvard Clinical Research Institute, Boston, MA (L.M.); and IDEV Technologies, Inc, Webster, TX (D.D., C.C.B.). krosenfield1@mgh.harvard.edu.
Abstract
BACKGROUND:Stent-based therapy in the superficial femoral and popliteal arteries in patients with peripheral artery disease is compromised by restenosis and risk of stent fracture or distortion. A novel self-expanding nitinol stent was developed that incorporates an interwoven-wire design (Supera stent, IDEV Technologies, Inc, Webster, TX) to confer greater radial strength, flexibility, and fracture resistance. METHODS AND RESULTS: This prospective, multicenter, investigational device exemption, single-arm trial enrolled 264 patients with symptomatic peripheral artery disease undergoing percutaneous treatment of de novo or restenotic lesions of the superficial femoral or proximal popliteal (femoropopliteal) artery. Freedom from death, target lesion revascularization, or any amputation of the index limb at 30 days (+ 7 days) postprocedure was achieved in 99.2% (258/260) of patients (P < 0.001). Primary patency at 12 months (360 ± 30 days) was achieved in 78.9% (180/228) of the population (P < 0.001). Primary patency by Kaplan-Meier analysis at 12 months (360 days) was 86.3%. No stent fracture was observed by independent core laboratory analysis in the 243 stents (228 patients) evaluated at 12 months. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford-Becker category in 88.7% of patients. CONCLUSIONS: The SUPERB Trial, an investigational device exemption study using an interwoven nitinol wire stent in the femoropopliteal artery, achieved the efficacy and safety performance goals predesignated by the Food and Drug Administration. On the basis of the high primary patency rate, absence of stent fracture, and significant improvements in functional and quality-of-life measures, the Supera stent provides safe and effective treatment of femoropopliteal lesions in symptomatic patients with peripheral artery disease. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00933270.
RCT Entities:
BACKGROUND: Stent-based therapy in the superficial femoral and popliteal arteries in patients with peripheral artery disease is compromised by restenosis and risk of stent fracture or distortion. A novel self-expanding nitinol stent was developed that incorporates an interwoven-wire design (Supera stent, IDEV Technologies, Inc, Webster, TX) to confer greater radial strength, flexibility, and fracture resistance. METHODS AND RESULTS: This prospective, multicenter, investigational device exemption, single-arm trial enrolled 264 patients with symptomatic peripheral artery disease undergoing percutaneous treatment of de novo or restenotic lesions of the superficial femoral or proximal popliteal (femoropopliteal) artery. Freedom from death, target lesion revascularization, or any amputation of the index limb at 30 days (+ 7 days) postprocedure was achieved in 99.2% (258/260) of patients (P < 0.001). Primary patency at 12 months (360 ± 30 days) was achieved in 78.9% (180/228) of the population (P < 0.001). Primary patency by Kaplan-Meier analysis at 12 months (360 days) was 86.3%. No stent fracture was observed by independent core laboratory analysis in the 243 stents (228 patients) evaluated at 12 months. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford-Becker category in 88.7% of patients. CONCLUSIONS: The SUPERB Trial, an investigational device exemption study using an interwoven nitinol wire stent in the femoropopliteal artery, achieved the efficacy and safety performance goals predesignated by the Food and Drug Administration. On the basis of the high primary patency rate, absence of stent fracture, and significant improvements in functional and quality-of-life measures, the Supera stent provides safe and effective treatment of femoropopliteal lesions in symptomatic patients with peripheral artery disease. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00933270.
Authors: Karla Maria Treitl; Benedikt Woerner; Regina Schinner; Michael Czihal; Susan Notohamiprodjo; Ulrich Hoffmann; Marcus Treitl Journal: Eur Radiol Date: 2017-02-06 Impact factor: 5.315
Authors: Kaspars Maleckis; Eric Anttila; Paul Aylward; William Poulson; Anastasia Desyatova; Jason MacTaggart; Alexey Kamenskiy Journal: Ann Biomed Eng Date: 2018-02-22 Impact factor: 3.934