Abstract
INTRODUCTION: Moderate-to-severe calcification is present in ~20%-30% of patients undergoing coronary angiography. Coronary lesion modification is often necessary to facilitate optimal stent delivery and expansion, with several dedicated devices now approved for calcium modification before stent implantation. The CYCLOPES study aims to evaluate an intravascular ultrasound (IVUS) based calcium modification algorithm for the treatment of moderate-to-severely calcified coronary lesions. METHODS AND ANALYSIS: CYCLOPES is a prospective, international, multi-center, observational, single-arm study. 500 patients will be enrolled at 25 centers in Europe. Patients with planned percutaneous coronary intervention (PCI) to a native coronary artery lesion with moderate-to-severe calcification will be eligible. All PCI procedures will be IVUS guided, with drug-eluting stents implanted according to the study-specific algorithm. The co-primary endpoints are the minimum stent area (MSA) at the site of maximum calcification at the end of the index procedure (as determined by core lab analysis), and target lesion failure (TLF) at 1-year post-procedure. Prespecified secondary endpoints include: the individual components of TLF at 1 month and 1 year; the MSA measured at the end of the index procedure; strategy success (defined as successful stent delivery with ≥ 80% stent expansion and complete stent apposition with no significant edge dissection and full lesion coverage with < 50% plaque burden at proximal and distal references with TIMI 3 flow); as well as target vessel revascularization; target lesion revascularization; stent thrombosis; cardiovascular death; and acute kidney injury at 1 year. Coronary angiograms and IVUS images will be analyzed by an independent core Lab. Clinical follow-up will be performed at discharge, 30-days, and 1 year post PCI. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06678594.