title: S.M.A.R.T. self-expanding nitinol stent for the treatment of atherosclerotic lesions in the superficial femoral artery (STROLL): 1-year outcomes.
abstract: OBJECTIVE
  To assess safety and efficacy of the S.M.A.R.T. Vascular Stent System (Cordis Corp, Fremont, California) in obstructive superficial femoral artery (SFA) disease.
  
  
  METHODS
  The single-arm, multicenter STROLL study (S.M.A.R.T. Nitinol Self-Expanding Stent in the Treatment of Obstructive Superficial Femoral Artery Disease) included 250 patients (250 lesions in SFA or proximal popliteal artery). The efficacy endpoint was primary patency defined by freedom from binary restenosis (peak systolic velocity ratio > 2.5) as derived by duplex ultrasound plus clinically driven target lesion revascularization (TLR) at 12 months.
  
  
  RESULTS
  Mean age of patients was 67.7 years ± 10.3; 47.2% of patients had diabetes; distribution of Rutherford/Becker classes 2, 3, and 4 was 45.8%, 51.4%, and 2.8%. Mean lesion length and reference vessel diameter were 77.3 mm ± 35.3 and 4.9 mm ± 0.7, respectively (23.6% cases with total occlusions). The 30-day freedom from major adverse events (death, index limb amputation, clinically driven TLR) was 100%. The 1-year primary patency was 81.7% by Kaplan-Meier estimate. The presence of diabetes or total occlusion had no effect on primary patency. Ankle-brachial index was 0.4-0.8 in 84.6% of patients at baseline and improved to > 0.8 in 81.0% of patients at 12 months. The proportion of patients in Rutherford/Becker class 3-4 was reduced from 54.2% at baseline to 8.0% at 12 months. Four patients (2.0%) experienced single-stent strut fracture (type I) at 1 year, without associated loss of stent patency.
  
  
  CONCLUSIONS
  The S.M.A.R.T. Vascular Stent System proved to be safe and effective for endovascular treatment of obstructive SFA and proximal popliteal artery disease, based on 1-year vessel patency and associated hemodynamic and clinical improvements.
authors.affiliation: Columbia Presbyterian Medical Center/New York Presbyterian Hospital, 161 Fort Washington Avenue, New York, NY 10032. Electronic address: wg2131@cumc.columbia.edu.
authors.forename: William A
authors.initials: WA
authors.lastname: Gray
authors.affiliation: Columbia St. Mary's Hospital, Milwaukee, Wisconsin.
authors.forename: Andrew
authors.initials: A
authors.lastname: Feiring
authors.affiliation: Vascular Surgery Associates, Huntsville, Alabama.
authors.forename: Marco
authors.initials: M
authors.lastname: Cioppi
authors.affiliation: Bryan LGH Heart Institute, Lincoln, Nebraska.
authors.forename: Robert
authors.initials: R
authors.lastname: Hibbard
authors.affiliation: Greenville Hospital, Greenville, South Carolina.
authors.forename: Bruce
authors.initials: B
authors.lastname: Gray
authors.affiliation: First Coast Cardiovascular Institute, Jacksonville, Florida.
authors.forename: Yazan
authors.initials: Y
authors.lastname: Khatib
authors.affiliation: PeaceHealth St. Joseph Medical Center, Bellingham, Washington.
authors.forename: David
authors.initials: D
authors.lastname: Jessup
authors.affiliation: Moffitt Heart and Vascular Group, PinnacleHealth CardioVascular Institute, Wormleysburg, Pennsylvania.
authors.forename: William
authors.initials: W
authors.lastname: Bachinsky
authors.affiliation: Amarillo Heart Clinical Research Institute, Amarillo, Texas.
authors.forename: Ernesto
authors.initials: E
authors.lastname: Rivera
authors.affiliation: Tri-Lakes Research, Hot Springs, Arizona.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Tauth
authors.affiliation: Cordis Clinical Research, Bridgewater, New Jersey.
authors.forename: Roberto
authors.initials: R
authors.lastname: Patarca
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts.
authors.forename: Joe
authors.initials: J
authors.lastname: Massaro
authors.affiliation: Cordis Clinical Research, Bridgewater, New Jersey.
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Stoll
authors.affiliation: Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
mesh_terms: D000368:Aged; D000497:Alloys; D050197:Atherosclerosis / Q000000981:diagnostic imaging* / Q000628:therapy*; D003251:Constriction, Pathologic; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging* / Q000628:therapy*; D015607:Stents; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D000497:Alloys; C013616:nitinol