DESyne BDS Plus RCT
Sponsor Name : Elixir Medical Corporation
The DESyne BDS Plus Randomised Clinical Trial (RCT) will seek to evaluate the safety, effectiveness and performance of the DESyne BDS Plus DECSS (Test) as compared to the CE Mark approved DESyne X2 Novolimus Eluting Coronary Stent System (DESyne X2 NECSS; DESyne X2) (Control) in the treatment of de novo native coronary artery lesions.
200 Patients will be enrolled at approximately 15 sites in Europe, New Zealand, and Brazil.
The primary endpoint is target lesion failure (TLF) at 3 days or through hospital discharge, whichever comes first. Target lesion failure (TLF) is defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically indicated target lesion revascularization.
o QCA: Late lumen loss at 6-month follow-up will be evaluated in the Imaging Subset to test for non-inferiority of DESyne BDS Plus to DESyne X2
Angiographic imaging will be undertaken to assess the vessel, lesion, and stent pre-procedure, during the procedure (peri-procedure), and postprocedure for all patients, and again at 6-month follow-up in the subset of approximately 60 patients (30 in each arm), in the selected imaging centers for the following parameters:
- Acute recoil
- % DS
OCT: OCT imaging assessment of the lesion and stent will be undertaken both at post-procedure and again at 6-month follow-up in approximately 60 patients (30 in each arm) included in the 6-month angiography subset in the selected imaging centers for the following parameters:
- Assessment of lumen, and device diameters, areas, and volumes
- Strut coverage
- Assessment of thrombus
- Descriptive analysis lesion and stent morphology
15 sites in Europe, New Zealand, and Brazil