title: First clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive disease.
abstract: BACKGROUND
  A novel self-expanding drug-eluting stent was designed to slowly release everolimus to prevent restenosis following peripheral arterial intervention. The purpose of the first-in-human Superficial Femoral Artery Treatment with Drug-Eluting Stents (STRIDES) trial was to evaluate the safety and efficacy of this device for the treatment of symptomatic superficial femoral and proximal popliteal arterial occlusive disease.
  
  
  RESULTS
  One hundred four patients were enrolled at 11 European investigative centers in a prospective, nonrandomized, single-arm trial. The patients had severe symptomatic vascular disease, including a significant proportion of patients with critical limb ischemia (17%), diabetes (39%), and single-vessel outflow (26%). The mean lesion length was 9.0 ± 4.3 cm. Ninety-nine percent of patients were available for 12-month follow-up, including duplex imaging in 90% and arteriography in 83%. Clinical improvement, defined as a sustained decrease in Rutherford-Becker clinical category, was achieved in 80% of patients. Primary patency (freedom from ≥50% in-stent restenosis) was 94 ± 2.3% and 68 ± 4.6% at 6 and 12 months, respectively. Plain radiographic examination of 122 implanted devices at 12 months revealed no evidence for stent fracture.
  
  
  CONCLUSIONS
  The everolimus-eluting self-expanding nitinol stent can be successfully implanted in patients with severe peripheral arterial disease with favorable outcomes and clinical improvements observed in the majority of patients.
authors.affiliation: Department of Cardiovascular and Interventional Radiology, Medical University, Vienna, Austria.
authors.forename: Johannes
authors.initials: J
authors.lastname: Lammer
authors.forename: Marc
authors.initials: M
authors.lastname: Bosiers
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.forename: Martin
authors.initials: M
authors.lastname: Schillinger
authors.forename: Els
authors.initials: E
authors.lastname: Boone
authors.forename: Margo J
authors.initials: MJ
authors.lastname: Zaugg
authors.forename: Patrick
authors.initials: P
authors.lastname: Verta
authors.forename: Lei
authors.initials: L
authors.lastname: Peng
authors.forename: Xingyu
authors.initials: X
authors.lastname: Gao
authors.forename: Lewis B
authors.initials: LB
authors.lastname: Schwartz
mesh_terms: D000368:Aged; D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003251:Constriction, Pathologic; D054855:Drug-Eluting Stents; D005060:Europe; D000068338:Everolimus; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D012720:Severity of Illness Index; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D000068338:Everolimus; D020123:Sirolimus