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

NCT ID: NCT01151033

Last Updated: 2011-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-09-30

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.

Conditions

Myocardial Ischemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

stent implantation

ProNOVA XR Polymer Free Drug Eluting Stent implantation - single arm

Group Type: EXPERIMENTAL

Drug Eluting Stent implantation

Intervention Type: DEVICE

ProNOVA XR Drug Eluting Stent implantation

Interventions

Drug Eluting Stent implantation

ProNOVA XR Drug Eluting Stent implantation

Intervention Type: DEVICE

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vascular Concepts Limited

INDUSTRY

Sponsor Role: collaborator

KCRI

OTHER

Sponsor Role: lead

Responsible Party

Vascular Concepts Limited

Principal Investigators

Dariusz Dudek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow

Locations

Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow

Krakow, , Poland

Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Sacz

Nowy Sącz, , Poland

Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Targ

Nowy Targ, , Poland

Countries

Poland

Other Identifiers

XR I

Identifier Type: -

Identifier Source: org_study_id