ALPHA LONG study

• Research type

  Research Study

• Full title

  A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of additional sizes of the BioMatrix AlphaTM (Cobalt Chromium Biolimus A9TM drug-eluting stent) – ALPHA LONG study

• IRAS ID

  327750

• Contact name

  Diana Schuette

• Contact email

  d.schuette@biosensors.com

• Sponsor organisation

  Biosensor Europe SA

• Clinicaltrials.gov Identifier

  NCT05799963

• Duration of Study in the UK

  3 years, 3 months, 16 days

• Research summary

  We aim to add 14 new BioMatrix Alpha stent sizes to the already CE marked size mix. For this we will aim to recruit 85 patients scheduled to undergo PCI of a de novo lesion(s) with reference vessel diameter and lesion length suitable for treatment with at least one study device. The patients will then be followed up at 9 and 24 months post index procedure time points for clinical endpoint collection described in the study primary endpoint section.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  23/LO/0657

• Date of REC Opinion

  26 Sep 2023

• REC opinion

  Further Information Favourable Opinion