Project
The Selution DeNovo Study
Ongoing - recruitment closed · 2023 until 2028
Rigger Johannes, Meier Jessica, Schneider Irene
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Study Design
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Additional Information
Brief description/objective
A prospective, randomized, multicenter, international, open, clinical study
in which the SELUTION DEB strategy was compared with the DES strategy.
Study objectives:
1) At 1 year, to demonstrate non-inferiority for TVF of a treatment strategy with first line SELUTION SLR DEB plus provisional DES vs. systematic treatment with DES for the treatment of de novo coronary lesions.
2) At 5-year follow-up, to demonstrate non-inferiority for TVF of the DEB vs. the systematic DES treatment strategy. In case non-inferiority is met, a test for superiority will be performed.