The objective of this study is the assessment of the performance, safety and efficacy of the ProNOVA XR Polymer Free Drug Eluting Stent System in the treatment of patients with de novo native coronary artery lesions.
This study is a prospective, single arm, multicenter registry of approximately 50 patients undergoing PCI with the ProNOVA Drug Eluting Coronary Stent System according to its Instructions for Use. The purpose of this registry is the evaluation of the performance, safety and efficacy of ProNOVA XR DES in real-world patients. Following initial stent implantation, all patients will have clinical follow up at 30 days, at 6 and 12 months. Additionally all patients will have a angiographic F/U at 6 months to assess the late luminal loss by QCA measurements and the neointimal volume including stent apposition by intravascular ultrasound.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
ProNOVA XR Drug Eluting Stent implantation
Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
Krakow, Poland
Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Sacz
Nowy Sącz, Poland
Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Targ
Nowy Targ, Poland
In-stent late luminal loss
Time frame: at 6 months after stent implantation
Clinically and non-clinically indicated target lesion revascularization
Time frame: at 30 days
Clinically and non-clinically indicated target vessel revascularization
Time frame: at 30 days
Incidence of total and cardiovascular death
Time frame: at 30 days
Incidence of nonfatal myocardial infarction
Time frame: at 30 days
Definite, probable, and possible stent thrombosis
Time frame: at 30 days
Clinically and non-clinically indicated target lesion revascularization
Time frame: at 6 months
Clinically and non-clinically indicated target vessel revascularization
Time frame: at 6 months
Incidence of total and cardiovascular death
Time frame: at 6 months
Incidence of nonfatal myocardial infarction
Time frame: at 6 months
Definite, probable, and possible stent thrombosis
Time frame: at 6 months
Clinically and non-clinically indicated target lesion revascularization
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Time frame: at 12 months
Clinically and non-clinically indicated target vessel revascularization
Time frame: at 12 months
Incidence of total and cardiovascular death
Time frame: at 12 months
Incidence of nonfatal myocardial infarction
Time frame: at 12 months
Definite, probable, and possible stent thrombosis
Time frame: at 12 months
In-stent and in-segment percent diameter stenosis (% DS)
Time frame: at 6 months after stent implantation
In-stent and in-segment binary restenosis rate as assessed by QCA
Time frame: at 6 months after stent implantation
In-stent and in-segment minimal luminal diameter (MLD)as assessed by QCA
Time frame: at 6 months after stent implantation
In-stent and in-segment late luminal loss as assessed by QCA
Time frame: at 6 months after stent implantation
Neointimal hyperplasia as assessed by intravascular ultrasound (IVUS)
Time frame: at 6 months after stent implantation
Rate of incomplete stent apposition as assessed by intravascular ultrasound (IVUS)
Time frame: at 6 months after stent implantation