FORWARD CAD IDE Study

• Research type

  Research Study

• Full title

  Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study of the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Coronary IVL Catheter (FORWARD CAD IDE Study)

• IRAS ID

  348952

• Contact name

  Denise Antonio

• Contact email

  dantonio@shockwavemedical.com

• Sponsor organisation

  Shockwave Medical, Inc

• Clinicaltrials.gov Identifier

  NCT06662500

• Duration of Study in the UK

  3 years, 3 months, 31 days

• Research summary

  The Shockwave Javelin Coronary IVL Catheter is a new medical device for angioplasty procedures where patients have narrowed blood vessel in their heart due to calcium where the vessels are completely blocked or almost completely blocked. Angioplasty opens blocked arteries and restores normal blood flow to the heart muscle by inflating a balloon to widen the artery. After the angioplasty, a stent (wire mesh tube) is placed in the artery to keep it opened.

  The new device can break up calcium in a narrowed blood vessel during the angioplasty procedure. This device is called the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Coronary IVL Catheter. This study will assess the use of the Javelin Coronary IVL Catheter.
  The Sponsor of this study, Shockwave Medical, makes this device.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  25/NW/0020

• Date of REC Opinion

  20 Feb 2025

• REC opinion

  Favourable Opinion