Project
Selution DeNovo Study
Scheduled ยท 2023 until 2030
Rigger Johannes, Meier Jessica, Schneider Irene
Type
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Brief description/objective
Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus any CE-marked DES strategy.
The study will test:
1) for non-inferiority of a DEB plus provisional DES treatment strategy versus a systematic DES strategy with respect to the primary endpoint of TVF at 12 months.
2) for long-term non-inferiority at 5 years of the DEB strategy with TVF as an endpoint and if met for long-term superiority at 5 years
All Subjects will be followed for clinical outcomes at 30 days, 6 months, 1 2, 3, 4 and 5 years.