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

Myocardial Ischemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151033
• Other study ID #: XR I
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 18, 2010
• Last updated: January 19, 2011
• Start date: November 2008
• Est. completion date: September 2010

Study information

• Verified date: January 2011
• Source: KCRI
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Device:
• Drug Eluting Stent implantation
ProNOVA XR Drug Eluting Stent implantation

Locations

Country	Name	City	State
Poland	Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow	Krakow
Poland	Oddzial Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Sacz	Nowy Sacz
Poland	Oddzial Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Targ	Nowy Targ

Sponsors (2)

Lead Sponsor	Collaborator
KCRI	Vascular Concepts Limited

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent late luminal loss		at 6 months after stent implantation	No
Secondary	Clinically and non-clinically indicated target lesion revascularization		at 30 days	Yes
Secondary	Clinically and non-clinically indicated target vessel revascularization		at 30 days	Yes
Secondary	Incidence of total and cardiovascular death		at 30 days	Yes
Secondary	Incidence of nonfatal myocardial infarction		at 30 days	Yes
Secondary	Definite, probable, and possible stent thrombosis		at 30 days	Yes
Secondary	Clinically and non-clinically indicated target lesion revascularization		at 6 months	Yes
Secondary	Clinically and non-clinically indicated target vessel revascularization		at 6 months	Yes
Secondary	Incidence of total and cardiovascular death		at 6 months	Yes
Secondary	Incidence of nonfatal myocardial infarction		at 6 months	Yes
Secondary	Definite, probable, and possible stent thrombosis		at 6 months	Yes
Secondary	Clinically and non-clinically indicated target lesion revascularization		at 12 months	Yes
Secondary	Clinically and non-clinically indicated target vessel revascularization		at 12 months	Yes
Secondary	Incidence of total and cardiovascular death		at 12 months	Yes
Secondary	Incidence of nonfatal myocardial infarction		at 12 months	Yes
Secondary	Definite, probable, and possible stent thrombosis		at 12 months	Yes
Secondary	In-stent and in-segment percent diameter stenosis (% DS)		at 6 months after stent implantation	No
Secondary	In-stent and in-segment binary restenosis rate as assessed by QCA		at 6 months after stent implantation	No
Secondary	In-stent and in-segment minimal luminal diameter (MLD)as assessed by QCA		at 6 months after stent implantation	No
Secondary	In-stent and in-segment late luminal loss as assessed by QCA		at 6 months after stent implantation	No
Secondary	Neointimal hyperplasia as assessed by intravascular ultrasound (IVUS)		at 6 months after stent implantation	No
Secondary	Rate of incomplete stent apposition as assessed by intravascular ultrasound (IVUS)		at 6 months after stent implantation	No