The objective of this study is to verify the safety and efficacy of the investigational
device (ELX1805J) for the treatment of ischemic heart disease due to de novo, native coronary
The Bioadaptor RCT Study is a prospective, 2:1 randomized study of parallel designed, that
will enroll up to 474 patients requiring treatment of up to two de novo coronary lesions of
24 mm in length in vessels of 2.5 mm and 3.5 mm in diameter.
One or two designated target lesions, located in separate epicardial vessels (RCA, LCX or
LAD), and meeting the inclusion/exclusion criteria may be treated with the ELX1805J (DynamX
Bioadaptor) or Resolute Onyx stent
The primary safety endpoint is Target Lesion Failure (TLF) at 12 months. TLF is a composite
endpoint defined as cardiac death, target vessel MI, and clinically-indicated target lesion
Additional secondary safety and effectiveness endpoints will be evaluated at 30 days, 6 and
12 months and 2-5 years.
Using visual assessment, the target lesion must measure 2.5 mm and 3.5 mm in diameter and
24 mm in length able to be covered by a single ELX1805J or Resolute Onyx stent including 2
mm of healthy vessel on either side of the planned treatment area.
The patient will be eligible for device implantation only after satisfactory lesion
pre-dilatation defined as: TIMI 2 flow, and no dissection greater than Grade B (NHLBI) able
to be covered with a single device
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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