SUCCESS PTA Trial - Revision D

• Research type

  Research Study

• Full title

  SUCCESS (SelUtion, safety, effiCaCy, hEalth economicS and promS) PTA Study

• IRAS ID

  296997

• Contact name

  Athanasios Diamantopoulos

• Contact email

  athanasios.diamantopoulos@nhs.net

• Sponsor organisation

  M.A. Med Alliance SA

• Clinicaltrials.gov Identifier

  NCT04776434

• Duration of Study in the UK

  5 years, 7 months, 1 days

• Research summary

  SUCCESS (SelUtion, safety, effiCaCy, hEalth economicS and promS) PTA Study
  The SELUTION SLR™ 018 PTA Balloon Catheter is the first Sustained Limus Release DEB specifically designed to treat peripheral artery disease. The safety and efficacy of this device have been demonstrated in the FIM trial (ClinicalTrials.gov ID: NCT02941224). This study aims to prospectively collect data on the use of SELUTION SLR DEB in order to generate post-market clinical follow-up (PMCF) data to prove safety and efficacy in an all-comers population of PAD patients.
  Design: Single study covering all peripheral indications (SFA, BTK, Foot); 722 patients; 50 sites in Europe, Asia, South America; FU up to 5 years.
  

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  22/LO/0101

• Date of REC Opinion

  13 Apr 2022

• REC opinion

  Further Information Favourable Opinion