The Selution DeNovo Study

Project

The Selution DeNovo Study

Ongoing - recruitment closed · 2023 until 2028

Rigger Johannes, Meier Jessica, Schneider Irene

Type

Clinical Studies

Range

Multicentric, KSSG as participating partner

Units

Kardiologie, Pflege Internistische Fachdisziplinen

Status

Ongoing - recruitment closed

Start Date

2023

End Date

2028

Financing

Industry

Study Design

Randomized, multi-centre, international, open label, clinical trial. Subjects meeting eligibility criteria will be randomized 1:1 to treatment of all lesions of the identified trial target vessel(s) with either the SELUTION SLRTM DEB or DES. 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.

Keywords

Prospektive, 1:1 randomisierte, internationale Studie, in der Selution DEB vs DES Strategie verglichen wird. IC: Angina oder pos. Ergo, stabi. NSTEMI; Läsionen behandelbar mit DEP resp. mit DES (>=2mm bis <=5mm), Stenose> 50% und <100%, distaler TIMI flow>=2. EC: STEMI oder instabiler NSTEMI; Killip und/ oder NYHA <3; LVEF <30%, frühere PCI innert 30 Tagen; CTO oder Instent Resteno

Homepage

http://Not applicable

Partner

Not applicable

Additional Information

Not applicable

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.