title: Bare metal stent versus paclitaxel eluting stent for intermediate length femoropopliteal arterial lesions (BATTLE trial): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Currently, endovascular treatment is indicated to treat femoropopliteal lesions ≤15 cm. However, the Achilles' heel of femoropopliteal endovascular repair remains restenosis. Paclitaxel eluting stents have shown promising results to prevent restenosis in femoropopliteal lesions compared to percutaneous transluminal angioplasty. A recently released prospective registry using a newer generation of self-expandable nitinol stents (Misago®; Terumo Corp., Tokyo, Japan) supports primary bare metal stenting as a first-line treatment for femoropopliteal lesions. To date, no studies have been designed to compare bare metal stents to paclitaxel eluting stents for the treatment of femoropoliteal lesions. The BATTLE trial was designed to compare paclitaxel eluting stents (Zilver® PTX®) and a last generation bare self-expandable nitinol stents (Misago® RX, Terumo Corp., Tokyo, Japan) in the treatment of intermediate length femoropopliteal lesions (≤14 cm).
  
  
  METHODS
  A prospective, randomized (1:1), controlled, multicentric and international study has been designed. One hundred and eighty-six patients fulfilling the inclusion criteria will be randomized to one of the two assessments of endovascular repair to treat de novo femoropopliteal lesions ≤14 cm in symptomatic patients (Rutherford 2 to 5): bare stent group and paclitaxel eluting stent group. The primary endpoint is freedom from in-stent restenosis at 1 year defined by a peak systolic velocity index >2.4 (restenosis of >50%) at the target lesion and assessed by duplex scan. Our main objective is to demonstrate the clinical superiority of primary stenting using Zilver® PTX® stent system versus bare metal self-expandable stenting in the treatment of femoropopliteal lesions in patients with symptomatic peripheral arterial disease.
  
  
  CONCLUSIONS
  This is the first randomized and controlled study to compare the efficacy of bare metal stents and paclitaxel eluting stents for the treatment of femoropopliteal lesions. It may clarify the indication of stent choice for femoropopliteal lesions of intermediate length.
  
  
  BACKGROUND
  Clinicaltrials.gov identifier: NCT02004951. 3 December 2013.
authors.affiliation: CHU Nantes, l'institut du thorax, service de chirurgie vasculaire, Nantes F-44000, France. yann.goueffic@chu-nantes.fr.
authors.forename: Yann
authors.initials: Y
authors.lastname: Gouëffic
authors.forename: Adrien
authors.initials: A
authors.lastname: Kaladji
authors.forename: Béatrice
authors.initials: B
authors.lastname: Guyomarch
authors.forename: Carine
authors.initials: C
authors.lastname: Montagne
authors.forename: Damien
authors.initials: D
authors.lastname: Fairier
authors.forename: Simon
authors.initials: S
authors.lastname: Gestin
authors.forename: Valéry-Pierre
authors.initials: VP
authors.lastname: Riche
authors.forename: Pierre Alexandre
authors.initials: PA
authors.lastname: Vent
authors.forename: Philippe
authors.initials: P
authors.lastname: Chaillou
authors.forename: Alain
authors.initials: A
authors.lastname: Costargent
authors.forename: Philippe
authors.initials: P
authors.lastname: Patra
mesh_terms: D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002985:Clinical Protocols; D003251:Constriction, Pathologic; D054855:Drug-Eluting Stents; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005263:Femoral Artery; D005602:France; D006801:Humans; D008670:Metals; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000628:therapy*; D011150:Popliteal Artery; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012107:Research Design; D015607:Stents; D013557:Switzerland; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D008670:Metals; D017239:Paclitaxel