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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia
• Intervention / Treatment: Device: Drug Eluting Stent implantation

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland
    • Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
  • Nowy Sacz, Poland
    • Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Sacz
  • Nowy Targ, Poland
    • Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Targ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stent implantation; ProNOVA XR Polymer Free Drug Eluting Stent implantation - single arm	Device: Drug Eluting Stent implantation; ProNOVA XR Drug Eluting Stent implantation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: KCRI
• Collaborators: Vascular Concepts Limited
• Investigators: Principal Investigator: Dariusz Dudek, MD, PhD, Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: June 18, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (Estimate): June 25, 2010

Study Record Updates

• Last Update Posted (Estimate): January 20, 2011
• Last Update Submitted That Met QC Criteria: January 19, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: stent; stent implantation; DES; coronary artery lesions; ProNOVA XR Polymer Free Drug Eluting Coronary Stent System; ProNOVA
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: XR I