MERLION Trial

Physician initiated, prospective, non-randomized Multi-center trial, investigating the safety and Efficacy of the tReatment with Luminor DCB and angiolite DES of IVascular in TASC C and D tibial Occlusive disease iN patients with critical limb ischaemia at 12-month follow up.

Device: luminor 14m or angiolite BTK

Number of patients: 50

Type of lesions: long tibial occlusive lesions TASC C and D

Clinical Primary Endpoint:

  • Freedom from Major Adverse Events (MAE) at 30 days
  • Freedom from major target limb amputation and clinically driven TLR within 6 months

Performance Primary Endpoint:

  • Freedom from clinically driven target lesion revascularization (TLR) within 12 months

Secondary endpoints

  • Primary patency rate at 6- and 12-month follow-up
  • Technical success
  • Freedom from clinically-driven TLR at 6-month follow-up
  • Improvement of Rutherford classification
  • Serious adverse events

Dr. Tang Tjun Yip, Singapore General Hospital, (Singapore, Singapore)

All Clinical Trials
TINTIN Trial
ANGIOLITE BTK Trial
EFFPAC Trial
BIBLIOS Trial
LUMINOR Registry