Back to resultsA Clinical Evaluation of the ProNOVA XR Polymer Free Drug Eluting Coronary Stent System (EURONOVA)
Primary Purpose
Myocardial Ischemia
Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Drug Eluting Stent implantation
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Ischemia focused on measuring ProNOVA XR Polymer Free Drug Eluting Coronary Stent System, DES, stent, coronary artery lesions, ProNOVA, stent implantation
Eligibility Criteria
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.
Sites / Locations
- Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
- Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Sacz
- Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Targ
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
stent implantation
Arm Description
ProNOVA XR Polymer Free Drug Eluting Stent implantation - single arm
Outcomes
Primary Outcome Measures
In-stent late luminal loss
Secondary Outcome Measures
Clinically and non-clinically indicated target lesion revascularization
Clinically and non-clinically indicated target vessel revascularization
Incidence of total and cardiovascular death
Incidence of nonfatal myocardial infarction
Definite, probable, and possible stent thrombosis
Clinically and non-clinically indicated target lesion revascularization
Clinically and non-clinically indicated target vessel revascularization
Incidence of total and cardiovascular death
Incidence of nonfatal myocardial infarction
Definite, probable, and possible stent thrombosis
Clinically and non-clinically indicated target lesion revascularization
Clinically and non-clinically indicated target vessel revascularization
Incidence of total and cardiovascular death
Incidence of nonfatal myocardial infarction
Definite, probable, and possible stent thrombosis
In-stent and in-segment percent diameter stenosis (% DS)
In-stent and in-segment binary restenosis rate as assessed by QCA
In-stent and in-segment minimal luminal diameter (MLD)as assessed by QCA
In-stent and in-segment late luminal loss as assessed by QCA
Neointimal hyperplasia as assessed by intravascular ultrasound (IVUS)
Rate of incomplete stent apposition as assessed by intravascular ultrasound (IVUS)
Full Information
NCT ID
NCT01151033
First Posted
June 18, 2010
Last Updated
January 19, 2011
Sponsor
KCRI
Collaborators
Vascular Concepts Limited
1. Study Identification
Unique Protocol Identification Number
NCT01151033
Brief Title
A Clinical Evaluation of the ProNOVA XR Polymer Free Drug Eluting Coronary Stent System
Acronym
EURONOVA
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
KCRI
Collaborators
Vascular Concepts Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
Keywords
ProNOVA XR Polymer Free Drug Eluting Coronary Stent System, DES, stent, coronary artery lesions, ProNOVA, stent implantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stent implantation
Arm Type
Experimental
Arm Description
ProNOVA XR Polymer Free Drug Eluting Stent implantation - single arm
Intervention Type
Device
Intervention Name(s)
Drug Eluting Stent implantation
Intervention Description
ProNOVA XR Drug Eluting Stent implantation
Primary Outcome Measure Information:
Title
In-stent late luminal loss
Time Frame
at 6 months after stent implantation
Secondary Outcome Measure Information:
Title
Clinically and non-clinically indicated target lesion revascularization
Time Frame
at 30 days
Title
Clinically and non-clinically indicated target vessel revascularization
Time Frame
at 30 days
Title
Incidence of total and cardiovascular death
Time Frame
at 30 days
Title
Incidence of nonfatal myocardial infarction
Time Frame
at 30 days
Title
Definite, probable, and possible stent thrombosis
Time Frame
at 30 days
Title
Clinically and non-clinically indicated target lesion revascularization
Time Frame
at 6 months
Title
Clinically and non-clinically indicated target vessel revascularization
Time Frame
at 6 months
Title
Incidence of total and cardiovascular death
Time Frame
at 6 months
Title
Incidence of nonfatal myocardial infarction
Time Frame
at 6 months
Title
Definite, probable, and possible stent thrombosis
Time Frame
at 6 months
Title
Clinically and non-clinically indicated target lesion revascularization
Time Frame
at 12 months
Title
Clinically and non-clinically indicated target vessel revascularization
Time Frame
at 12 months
Title
Incidence of total and cardiovascular death
Time Frame
at 12 months
Title
Incidence of nonfatal myocardial infarction
Time Frame
at 12 months
Title
Definite, probable, and possible stent thrombosis
Time Frame
at 12 months
Title
In-stent and in-segment percent diameter stenosis (% DS)
Time Frame
at 6 months after stent implantation
Title
In-stent and in-segment binary restenosis rate as assessed by QCA
Time Frame
at 6 months after stent implantation
Title
In-stent and in-segment minimal luminal diameter (MLD)as assessed by QCA
Time Frame
at 6 months after stent implantation
Title
In-stent and in-segment late luminal loss as assessed by QCA
Time Frame
at 6 months after stent implantation
Title
Neointimal hyperplasia as assessed by intravascular ultrasound (IVUS)
Time Frame
at 6 months after stent implantation
Title
Rate of incomplete stent apposition as assessed by intravascular ultrasound (IVUS)
Time Frame
at 6 months after stent implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dariusz Dudek, MD, PhD
Organizational Affiliation
Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
City
Krakow
Country
Poland
Facility Name
Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Sacz
City
Nowy Sacz
Country
Poland
Facility Name
Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Targ
City
Nowy Targ
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
A Clinical Evaluation of the ProNOVA XR Polymer Free Drug Eluting Coronary Stent System
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