A Clinical Evaluation of the ProNOVA XR Polymer Free Drug Eluting Coronary Stent System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Clinical Evaluation of the ProNOVA XR Polymer Free Drug Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions

Conditions
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Myocardial Ischemia

Intervention / Treatment
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* Device: Drug Eluting Stent implantation


Participation Criteria
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Eligibility Criteria
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General Inclusion Criteria: Patient must be at least 18 years of age. Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ProNOVA XR DES and she or her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia) Patient must agree to undergo all required follow-up examinations. Patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment. Angiographic Inclusion Criteria: Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy) Target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate Target lesion ≤ 28 mm in length by visual estimate Exclusion Criteria: Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year) Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, cobalt, chromium, nickel, or contrast sensitivity that cannot be adequately pre-medicated Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stent implantation<br>ProNOVA XR Polymer Free Drug Eluting Stent implantation - single arm | Device: Drug Eluting Stent implantation<br>* ProNOVA XR Drug Eluting Stent implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent late luminal loss |  | at 6 months after stent implantation | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ProNOVA XR Polymer Free Drug Eluting Coronary Stent System, DES, stent, coronary artery lesions, ProNOVA, stent implantation