Mini C Flex Feasibility Study

• Research type

  Research Study

• Full title

  Prospective, Multicenter, Single-Arm, Feasibility Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave Mini C Flex Coronary IVL Catheter. (Mini C Flex Feasibility Study)

• IRAS ID

  321902

• Contact name

  James Spratt

• Contact email

  james.spratt@nhs.net

• Sponsor organisation

  Shockwave Medical, Inc.

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  To assess the safety and performance of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Mini C Flex IVL Catheter for treatment of calcified, stenotic de novo coronary arteries prior to stenting.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  23/LO/0141

• Date of REC Opinion

  13 Apr 2023

• REC opinion

  Further Information Favourable Opinion