Optimal - ECRI 13

• Research type

  Research Study

• Full title

  Study title: OPtimizaTIon of Left MAin PCI with IntravascuLar Ultrasound. The OPTIMAL Randomized Controlled Trial

• IRAS ID

  275334

• Contact name

  G.L. De Maria

• Contact email

  giovanniluigi.demaria@ouh.nhs.uk

• Sponsor organisation

  ECRI Institute

• Clinicaltrials.gov Identifier

  NCT04111770

• Duration of Study in the UK

  4 years, 6 months, 1 days

• Research summary

  The OPTIMAL study is a randomized, controlled, multicenter, international study to assess which method is best used to visualize the coronary arteries during a percutaneous coronary intervention (PCI) of the left main coronary artery ; The two methods compared are IntraVascular UltraSound and Angiographic guided PCI.
  A total of 800 participants will be randomized in a 1:1 fashion to IVUS-guided PCI versus qualitative angio-guided PCI, stratified by site. Patients will be consented prior to the PCI procedure and then followed up to 2 years after the index procedure.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  20/SC/0041

• Date of REC Opinion

  18 Feb 2020

• REC opinion

  Favourable Opinion