Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:
The TECTONIC CAD IVL IDE Study is a prospective, single-arm, open-label, multi-center study to evaluate the safety and effectiveness of the Abbott Coronary IVL System to treat severely calcified, stenotic de novo coronary arteries prior to stenting in 335 subjects at up to 55 sites in the US. The clinical outcomes from the study will be compared to pre-specified performance goals (PG) established using medical/scientific literature. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the Abbott Coronary IVL System in the United States.
