This is a prospective, multi-center, single-arm, open-label, First in Human clinical trial.
Clinical follow-up for all patients will be performed at 30 days, 6 months, 1 year after the procedure, and then until 5 years.
The enrollment was finalized in June 2023 with a total of 60 subjects were enrolled in 04 investigational sites in Israel and Brazil. All patients will undergo optical coherence tomography (OCT) imaging at baseline (pre and post stenting procedure) and follow up angiography and OCT imaging at either 1 month or 13 months. The first 15 consecutively implanted patients with will be assigned to 1 month (cohort A, N=15) angiographic and OCT follow-up, while the remaining 45 implanted patients will be assigned to 13 months (cohort B, N=45) angiographic and OCT follow-up.
Sponsor
Study objectives
To provide preliminary evidence for the safety and efficacy of the novel IoNIR stent system.
Primary endpoints
1. In-stent Late Loss (LL) at 13 months (cohort B) assessed by quantitative coronary angiography (QCA) (Minimal Lumen Diameter (MLD) post-procedure – MLD follow-up).
2. Target Lesion Failure (composite of cardiovascular death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year.
CERC Services
- CEC and DSMB activities
- CIP & ICF review
- CoreLab activities
- CRF and Data management
- Project management
- Publication review
- Statistical Analysis and Clinical report
Countries
Israel and Brazil
Number of investigational sites
4
