TRANSFORM II

• Research type

  Research Study

• Full title

  TRANSFORMII: Sirolimus-coated balloon versus drug-eluting stent in native coronary vessels

• IRAS ID

  311297

• Contact name

  Sandeep Basavarajaiah

• Contact email

  sandeep270478@gmail.com

• Sponsor organisation

  Fondazione Ricerca e Innovazione Cardiovascolare ETS

• Clinicaltrials.gov Identifier

  NCT04893291

• Duration of Study in the UK

  7 years, 0 months, 28 days

• Research summary

  This study is international, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial that observe and evaluate the efficacy, of Magic Touch SCB compared to one of the gold standard treatment for native vessel disease (everolimus-eluting stent, EES).

  Both devices have CE marking certificates and meet European Union rules and regulations. They are both used for the treatment of narrowing in coronary arteries, in accord with current local clinical practice. This study will be carried out in order to verify that the Magic Touch SCB is at least as good as the everolimus-eluting DES (EES). The primary objective of the study is to verify the non-inferiority of Magic Touch SCB compared to everolimus-eluting DES (EES) in terms of TLF, a composite clinical endpoint, at 12 months.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  22/NW/0280

• Date of REC Opinion

  7 Oct 2022

• REC opinion

  Further Information Favourable Opinion