eTRYTON Left main Registry

• Research type

  Research Study

• Full title

  A multi-centre prospective registry evaluating the Tryton Side Branch Stent for the treatment of de novo coronary arterial disease involving both the Left Main and Circumflex Coronary Artery

• IRAS ID

  212244

• Contact name

  Peter O'Kane

• Contact email

  peter.o'kane@rbch.nhs.uk

• Sponsor organisation

  Vascular Perspectives Ltd

• Clinicaltrials.gov Identifier

  NCT02765646

• Duration of Study in the UK

  1 years, 3 months, 1 days

• Research summary

  The registry is a prospective, muli centre, non randomised, observational single arm registry that will involve the collection of demographic and clinical data of patients that are treated with theTryton side Branch stent, for de novo coronary arterial disease involving both the Left Main and Circumflex Coronary Arteries. The data collected will determine the primary composite endpoint of MACE (Major Adverse Cardiac Events) at 9 months and secondary endpoints including procedural success, SAEs and followup status. Recruitment is estimated to 10 patients at this site. The objective of the trial is to demonstrate the clinical performance of the Tryton Side Branch used in conjunction with a commercially available Drug Eluting Stent to treat the de Novo bifurcated lesions.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  16/NE/0417

• Date of REC Opinion

  28 Dec 2016

• REC opinion

  Unfavourable Opinion