A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Subjects must meet all the following criteria to participate in the trial:
* Subject age is ≥ 18 years (or 21 according to countries legal age)
* Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure or are using a contraceptive device or drug.
* Documented angina and/or positive functional testing or unstable angina or stabilized NSTEMI presentation.
* Life expectancy \>1 year
* Written informed consent by the subject or her/his legally authorized representative for participation in the study
* One or more native target vessel (LAD, LCX or RCA) is considered to require intervention and is suitable for treatment of all lesions with either DEB + provisional stenting or with DES and is identified as such.
* The number of trial target lesions is not limited, but in the operator's opinion, if the subject is randomized to the DEB arm, the likelihood of the subject requiring provisional stenting of any of the identified trial target lesions is \< 30%, and if randomized to the systematic DES arm, all lesions are considered amenable to stenting.
* All target lesions: diameter between 2.0 and 5 mm, and diameter stenosis \>50% and \<100% with distal flow at least TIMI 2
Exclusion Criteria:
Age \< 18 years (or 21 according to countries legal age)
* Subject is pregnant or breast-feeding
* Definite or suspected clinically active covid-19 infection
* Subject is under judicial protection, tutorship or curatorship (for France only)
* Subjec…