Prospective single arm CAS - ROADSAVER study

• Research type

  Research Study

• Full title

  Prospective, single-arm, multi-center, observational study to further confirm safety and efficacy of the dual-layer micromesh Roadsaver™ Carotid Stent for the treatment of carotid artery stenosis in patients considered eligible for elective stenting procedure

• IRAS ID

  245074

• Contact name

  Tamara Sals

• Contact email

  tamara.sals@terumo-europe.com

• Sponsor organisation

  Terumo Interventional Systems

• Clinicaltrials.gov Identifier

  NCT03504228

• Duration of Study in the UK

  2 years, 5 months, 29 days

• Research summary

  The purpose of ROADSAVER study is to further confirm the safety and efficacy of
  the RoadsaverTM Carotid Stent device for the treatment of carotid artery stenosis
  in patients considered eligible for elective stenting procedure. Detection of rare events in a large population, Assessment of radial or femoral access site utilization and its impact on safety and efficacy outcomes, Assessment of ROADSAVER Carotid Stent performance by routinely used imaging modalities. No additional tests or procedures are required, all treatments will be according to routine hospital practice.

• REC name

  North East - York Research Ethics Committee

• REC reference

  18/NE/0245

• Date of REC Opinion

  20 Jul 2018

• REC opinion

  Favourable Opinion