title: The Zilver® PTX® Single Arm Study: 12-month results from the TASC C/D lesion subgroup.
abstract: OBJECTIVE
  The aim of the present article was to report the 12-month results of the Zilver® PTX® Single Arm StudyTASC C/D de novo lesion subgroup.
  
  
  METHODS
  The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. This is a prospective, single-arm, multicentre clinical study evaluating the Zilver PTX Drug-Eluting Peripheral Stent for treating patients with symptomatic lesions in the above-the-knee femoropopliteal artery. This study enrolled 787 patients (900 lesions) with Rutherford class 2 or higher treated with the Zilver PTX stent; 135 were long de novo lesions, corresponding to TASC II Class C or D.
  
  
  RESULTS
  The 135 long lesions had a mean length of 226.1±43.6 mm. The 12-month Kaplan-Meier estimates included a 77.6% primary patency rate, an 84.7% event-free survival rate, and an 85.4% rate of freedom from target lesion revascularization (TLR). The 12-month stent fracture rate was 2.1%.
  
  
  CONCLUSIONS
  The primary patency rates in the analysis of the TASC C/D de novo lesion subgroup of the Zilver PTX Single Arm Study indicate that endovascular therapy outcomes with a paclitaxel eluting stent may equal those of bypass surgery. Endovascular treatment with DES may play an important role for treatment of patients who present with TASC C or D femoropopliteal lesions.
authors.affiliation: Department of Vascular Surgery, AZ St-Blasius, Dendermonde, Belgium. marc.bosiers@telenet.be
authors.forename: M
authors.initials: M
authors.lastname: Bosiers
authors.forename: P
authors.initials: P
authors.lastname: Peeters
authors.forename: J
authors.initials: J
authors.lastname: Tessarek
authors.forename: K
authors.initials: K
authors.lastname: Deloose
authors.forename: S
authors.initials: S
authors.lastname: Strickler
mesh_terms: D000368:Aged; D054855:Drug-Eluting Stents; D057510:Endovascular Procedures / Q000379:methods*; D005260:Female; D005263:Femoral Artery / Q000503:physiopathology / Q000601:surgery*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D017239:Paclitaxel / Q000494:pharmacology*; D058729:Peripheral Arterial Disease / Q000503:physiopathology / Q000601:surgery*; D011150:Popliteal Artery / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D011474:Prosthesis Design; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D017239:Paclitaxel