The ROADSTER Plus Study - SRM-2012-02

• Research type

  Research Study

• Full title

  INVESTIGATION of FLOW ALTERED, SHORT TRANSCERVICAL CAROTID ARTERY STENTING in PATIENTS with SIGNIFICANT CAROTID ARTERY DISEASE with filter. The ROADSTER Plus Study

• IRAS ID

  110963

• Contact name

  Drisumaira Macdonald

• Sponsor organisation

  Silk Road Medical, Inc.

• Eudract number

  N/A

• ISRCTN Number

  N/A

• Research summary

  The ROADSTER Plus study will evaluate the safety and usability of the MICHI Neuroprotection'system. This system is a variation of the embolic protection devices currently used in routine practice during Carotid Artery Stenting (CAS) procedures at the Freeman research Hospital. The device is thought to improve the safety profile of patientsneeding stends in their carotid arteries.

• REC name

  North East - York Research Ethics Committee

• REC reference

  12/NE/0387

• Date of REC Opinion

  28 Jan 2013

• REC opinion

  Further Information Favourable Opinion