Project

Selution DeNovo Study

Scheduled ยท 2023 until 2030

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Scheduled
Start Date
2023
End Date
2030
Financing
Industry
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.