The BARD® Venous Stent - VERNACULAR study

• Research type

  Research Study

• Full title

  The BARD® Venous Stent - A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease – an Assessment for Effectiveness and Safety (VERNACULAR)

• IRAS ID

  201246

• Contact name

  winfried huesmann

• Contact email

  winfried.huesmann@crbard.com

• Sponsor organisation

  Bard Peripheral Vascular, Inc.

• Clinicaltrials.gov Identifier

  NCT02655887

• Duration of Study in the UK

  4 years, 0 months, 0 days

• Research summary

  The BARD VENOVO Venous Stent Study is a prospective, multi-centre, non-randomised, single-arm clinical study intended to collect evidence of the safety and effectiveness of the VENOVO Venous Stent system, for the treatment of iliofemoral occlusive disease including Acute or Chronic Deep Vein Thombosis (DVT), May-Thurner Syndrome, or any combination of the above.
  The study will be conducted at a maximum of 35 investigational sites in the United States, Europe and Australia/New Zealand. Bard plans for enrolment to continue until a maximum of one-hundred seventy 170 subjects are treated with the VENOVO Venous Stent over a 12-month timeframe. No more than 34 treated subjects may be enrolled at any site. Data will be collected from clinical follow-up up to 36months post-index procedure.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  16/LO/1045

• Date of REC Opinion

  30 Sep 2016

• REC opinion

  Further Information Favourable Opinion