STUDY DETAILS

To observe and evaluate the performance of a Sirolimus-eluting Drug-Coated Balloon (SCB) for the treatment of any type of coronary lesions, including native vessel disease and in-stent restenosis.
Prospective, multi-center, spontaneous clinical registry.
External validation of quality of data input, Centralised clinical event assessment.
Real world, all comers patients, consecutive enrollment.
2000 patients at 45 European/Asiatic sites.
Clinical follow up to 36 months.

  • Chairman
    Bernardo Cortese, Italy
  • Co-chairman
    Prof. Antonio Colombo, Italy
STUDY ENDPOINTS

Primary Endpoint:
Target Lesion Revascularization (TLR) at 12 months.

Secondary Endpoint:
MACE (Major Adverse Cardiac Events) as a composite of cardiac death, myocardial infarction (MI) and TLR at 6, 12, 24 and 36 months; any individual element of MACE;
Procedural success (defined as technical and angiographic success in the absence of MACE during hospitalization).