Prospective, multicenter, single arm study, to assess the feasibility and safety of the Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native vessels.
Prospective, multicenter, open-label and single arm study, conducted in 3 interventional cardiology centers in The Netherlands. The objective is to assess the feasibility and safety of the Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native vessels. In total, 35 patients will be enrolled. All patients will be treated with Axetis Inert Coronary Stent System. All patients will undergo repeat angiography at 6 months follow-up. Quantitative coronary angiography (QCA) assessment will be performed at baseline (pre- and post-procedure) and at 6 months follow-up. All patients will undergo Optical coherence Tomography (OCT) investigation at baseline (post procedure) and at 6 months follow-up. The primary endpoint is in-stent Late Lumen Loss (LLL) at 6 months after stent implantation as assessed by off-line QCA. Clinical follow-up will occur at 6 and 12 months post-stent implantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
de novo coronary artery stenosis in native vessels
AMC Amsterdam, Netherlands
Amsterdam, Netherlands
RECRUITINGThoraxcentrum Twente, Medisch Spectrum
Enschede, Netherlands
RECRUITINGSt. Antonius
Nieuwegein, Netherlands
RECRUITINGIn-stent Late Lumen Loss (LLL) assessed by off-line QCA
Time frame: 6 months after stent implantation
Acute Lumen gain
Angiographic endpoint MLD (mm); Diameter Stenosis (%); Binary Restenosis (DS ≥50%)
Time frame: Post intervention (1 hour)
Acute area gain
Optical coherence tomography end point
Time frame: Post intervention (1 hour)
Percent Acute device success
Device-oriented Composite Endpoints (DoCE) at 6 months and 12 months (DoCE is defined as Cardiac Death, MI not clearly attributable to a nonintervention vessel, and clinically-indicated Target Lesion Revascularization and its individual components) Stent thrombosis according to the ARC definitions up to 12 months follow-up
Time frame: 1 day post intervention
late lumen loss
Angiographic endpoint
Time frame: 6 months after intervention
maximal neointimal thickness
OCT
Time frame: 6 months after intervention
Percent procedural success
Time frame: post intervention (1 hour)
Number of adverse cardiac events
clinical endpoint
Time frame: 12 months after intervention
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