ULTRA LONG study

• Research type

  Research Study

• Full title

  A Prospective Multi-center Single Arm Trial to Assess the Safety and Effectiveness of Longer Length BioFreedomTM Ultra CoCr Biolimus A9TM Coated Coronary Stents (ULTRA LONG)

• IRAS ID

  327777

• Contact name

  Diana Schuette

• Contact email

  d.schuette@biosensors.com

• Sponsor organisation

  Biosensor Europe SA

• Clinicaltrials.gov Identifier

  NCT05643430

• Duration of Study in the UK

  3 years, 3 months, 13 days

• Research summary

  We aim to add 14 new BioFreedom Ultra stent sizes to the already CE marked size mix. For this we will aim to recruit 86 high bleeding risk (HBR) patients with either chronic coronary syndromes, unstable angina or non-ST elevation myocardial infarction who have an indication for percutaneous coronary intervention (PCI) and are unsuitable for dual anti-platelet therapy (DAPT) longer than 1 month. The patients will then be followed up at 1, 9 and 24 months post index procedure time points for clinical endpoint collection described in the study primary endpoint section.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  23/SC/0261

• Date of REC Opinion

  2 Aug 2023

• REC opinion

  Favourable Opinion