This is a prospective, multicenter, single-arm clinical study. The objective is to enroll up to 60 patients requiring percutaneous coronary intervention (PCI) on up to two de novo coronary artery lesions with reference vessel diameters ≥ 2.25 mm and ≤ 3.5 mm, and lesion lengths of ≤ 34 mm, with moderate to severe calcification.
Up to two de novo moderately to severely calcified coronary artery lesions located in separate epicardial vessels (RCA, LCX or LAD) which meet the inclusion/exclusion criteria may be treated with the LithiX Coronary HCLC to prepare the lesion prior to stenting.
All patients will undergo coronary angiography to assess the final residual stenosis immediately post-LithiX Coronary HCLC treatment and post stenting.
In the Optical Coherence Tomography (OCT) imaging subgroup,
approximately 30 patients will undergo OCT imaging at pre-procedure, post-LithiX Coronary HCLC treatment, and the end of procedure following stent deployment.
All angiographic and OCT images will be analyzed by the independent core laboratory.
Stent implantation is performed per standard practice.
Subjects will be followed through hospital discharge and will have clinical follow-up conducted by phone at 30 days and 6 months post-index procedure.
Sponsor
Study objectives
The objective of to assess safety and performance of the LithiX Coronary HCLC to treat moderately to severely calcified coronary artery lesions by percutaneous transluminal coronary angioplasty (PTCA).
Primary endpoints
The primary safety endpoint is the major adverse cardiovascular events (MACE) through 30 days. MACE is defined as a per-subject composite endpoint of cardiovascular death, myocardial infarction, and target vessel revascularization.
The primary performance endpoint is the clinical success defined as residual stenosis <50% after final treatment (with or without stenting) with no evidence of in-hospital MACE.
CERC Services
- Project management
- Clinical trial documentation
- CoreLab activities
- CRF and Data management
- Statistical Analysis
- TMF set-up and maintenance
Countries
Belgium, Netherlands
Number of investigational sites
7
Number of patients
60
