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| Name | Class |
|---|---|
| Vascular Concepts Limited | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stent implantation | Experimental | ProNOVA XR Polymer Free Drug Eluting Stent implantation - single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug Eluting Stent implantation | Device | ProNOVA XR Drug Eluting Stent implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-stent late luminal loss | at 6 months after stent implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically and non-clinically indicated target lesion revascularization | at 30 days | |
| Clinically and non-clinically indicated target vessel revascularization | at 30 days | |
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General Inclusion Criteria:
Angiographic Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dariusz Dudek, MD, PhD | Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow | Krakow | Poland |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Incidence of total and cardiovascular death |
| at 30 days |
| Incidence of nonfatal myocardial infarction | at 30 days |
| Definite, probable, and possible stent thrombosis | at 30 days |
| Clinically and non-clinically indicated target lesion revascularization | at 6 months |
| Clinically and non-clinically indicated target vessel revascularization | at 6 months |
| Incidence of total and cardiovascular death | at 6 months |
| Incidence of nonfatal myocardial infarction | at 6 months |
| Definite, probable, and possible stent thrombosis | at 6 months |
| Clinically and non-clinically indicated target lesion revascularization | at 12 months |
| Clinically and non-clinically indicated target vessel revascularization | at 12 months |
| Incidence of total and cardiovascular death | at 12 months |
| Incidence of nonfatal myocardial infarction | at 12 months |
| Definite, probable, and possible stent thrombosis | at 12 months |
| In-stent and in-segment percent diameter stenosis (% DS) | at 6 months after stent implantation |
| In-stent and in-segment binary restenosis rate as assessed by QCA | at 6 months after stent implantation |
| In-stent and in-segment minimal luminal diameter (MLD)as assessed by QCA | at 6 months after stent implantation |
| In-stent and in-segment late luminal loss as assessed by QCA | at 6 months after stent implantation |
| Neointimal hyperplasia as assessed by intravascular ultrasound (IVUS) | at 6 months after stent implantation |
| Rate of incomplete stent apposition as assessed by intravascular ultrasound (IVUS) | at 6 months after stent implantation |
| Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Sacz | Nowy Sącz | Poland |
| Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Targ | Nowy Targ | Poland |