EMINENT

• Research type

  Research Study

• Full title

  A randomized trial comparing the ELUVIA™ drug-eluting stent versus bare metal self-expanding nitinol stents in the treatment of superficial femoral and/or proximal popliteal arteries.

• IRAS ID

  218039

• Contact name

  Lieve Cornelis

• Contact email

  lieve.cornelis@bsci.com

• Sponsor organisation

  Boston Scientific International SA

• Clinicaltrials.gov Identifier

  NCT02921230

• Duration of Study in the UK

  5 years, 0 months, 0 days

• Research summary

  EMINENT is a prospective, randomised, multi-center study to proof that in treatment of narrowing (or stenosis) of the arteries in the upper leg (Superficial Femoral Artey (SFA) and/or Proximal Popliteal Artery (PPA)), the ELUVIA stent is superior versus several self-expanding Bare Nitinol Stent commercially available on the market.
  Study population are subjects with a stenotic lesion of 30-140mm long in the SFA and/or PPA that are presenting symptoms classified as Rutherford 2-4 catgeory. The ELUVIA Stent System is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions in the native SFA and/or PPA with reference vessel diameters (RVD) ranging from 4.0-6.0 mm and total lesion lengths up to 140 mm.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  16/LO/2126

• Date of REC Opinion

  27 Jan 2017

• REC opinion

  Further Information Favourable Opinion